The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Modification To Vsm- Vital Signs Monitor, (vsm 300 ).
| Device ID | K063419 |
| 510k Number | K063419 |
| Device Name: | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Contact | Jeffrey Wagner |
| Correspondent | Jeffrey Wagner 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2006-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094033687 | K063419 | 000 |