The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Vital Signs Monitor, Propaq Lt.
| Device ID | K033378 |
| 510k Number | K033378 |
| Device Name: | VITAL SIGNS MONITOR, PROPAQ LT |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Contact | Dave Klementowski |
| Correspondent | Dave Klementowski WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2004-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094120981 | K033378 | 000 |
| 00732094063776 | K033378 | 000 |
| 00732094063752 | K033378 | 000 |
| 00732094063714 | K033378 | 000 |
| 00732094063547 | K033378 | 000 |
| 00732094063523 | K033378 | 000 |
| 00732094063509 | K033378 | 000 |
| 00732094063387 | K033378 | 000 |
| 00732094063363 | K033378 | 000 |
| 00732094063349 | K033378 | 000 |
| 00732094063301 | K033378 | 000 |
| 00732094063288 | K033378 | 000 |
| 00732094063790 | K033378 | 000 |
| 00732094063806 | K033378 | 000 |
| 00732094120905 | K033378 | 000 |
| 00732094064216 | K033378 | 000 |
| 00732094064087 | K033378 | 000 |
| 00732094064063 | K033378 | 000 |
| 00732094064049 | K033378 | 000 |
| 00732094064025 | K033378 | 000 |
| 00732094064001 | K033378 | 000 |
| 00732094063882 | K033378 | 000 |
| 00732094063868 | K033378 | 000 |
| 00732094063851 | K033378 | 000 |
| 00732094063837 | K033378 | 000 |
| 00732094063264 | K033378 | 000 |