FDA 510(k) · Pro-Tech Services
K033402: PORTABLE SLEEP DATA RECORDER (PSDR) (Pro-Tech Services, Inc.)
Pro-Tech Services, Inc. received FDA 510(k) K033402 for PORTABLE SLEEP DATA RECORDER (PSDR), with a decision date of Jun 30, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K033402 |
|---|---|
| Pathway | 510(k) |
| Applicant | Pro-Tech Services, Inc. |
| Device name | PORTABLE SLEEP DATA RECORDER (PSDR) |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Oct 24, 2003 |
| Decision date | Jun 30, 2004 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The PSDR system is a physiological recorder intended to display and to record for later play back of oxygen saturation, pulse rate, airflow, thoracic and abdominal respiratory effort, periodic limb movement, body position data, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment. Prescription Use - XX OR Over-The-Counter Use (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER ['AGE IF NEEDED) Concurrence of CDRHI, Office of Device Evaluation (ODE) (Optional Format 3-10-98) (PostedJuly 1, 1998) Indications For Use (Division Sign-O Division of Anesth, ,y, General Hospital, Infection Control, .,.,!Devices 510(k) Number ~ 0-b3 40dK -6-
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
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 Other. These are heuristics, not FDA fields.