FDA 510(k) · Itamar
K081982: WATCH-PAT 200S-2 (WP200S-2) (Itamar Medical)
Itamar Medical received FDA 510(k) K081982 for WATCH-PAT 200S-2 (WP200S-2), with a decision date of Aug 14, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K081982 |
|---|---|
| Pathway | 510(k) |
| Applicant | Itamar Medical |
| Device name | WATCH-PAT 200S-2 (WP200S-2) |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Jul 11, 2008 |
| Decision date | Aug 14, 2008 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statement 510(k) Number (if known): 1<, O 4 $ ; Device Name: Indications for Use: The Watch-PAT200S-2 (WP200S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP200S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index (CPRDI"), Apnea-Hypopnea index (CPAHI') and PAT sleep staging identification (PSTAGES). The WP200S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP200S-2's PSTAGES is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The WP200S-2 is not indicated for children less than 17 years old. (Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: j(o, 1 cj%-2 _ Prescription Use X AND/OR Over-The-Counter Use (Per 21 C.F.R. 801.109) (Per 21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) \\VDC 087424/O0000 ] 2754964 vl
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K081982
- K102567 WATCH-PAT 200S-3 (WP200S-3) (Itamar, Jun 2, 2011, MNR)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Wrist PPG. These are heuristics, not FDA fields.