FDA 510(k) · Itamar
K081037: WATCH-PAT 200I (WP200I) (Itamar Medical)
Itamar Medical received FDA 510(k) K081037 for WATCH-PAT 200I (WP200I), with a decision date of Jun 9, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K081037 |
|---|---|
| Pathway | 510(k) |
| Applicant | Itamar Medical |
| Device name | WATCH-PAT 200I (WP200I) |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Apr 11, 2008 |
| Decision date | Jun 9, 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): K081037 Device Name: WATCH PATTM 200i Indications for Use: The WATCH PAT TM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI'), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM 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 WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy. 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 CDce ofD vicE tion (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: KOT /0'o 7
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.
- K042916 WATCH PAT 100S (Itamar)
Later records that cite K081037
- K081982 WATCH-PAT 200S-2 (WP200S-2) (Itamar, Aug 14, 2008, 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.