The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Micropaq, Models 402, 404.
| Device ID | K021681 |
| 510k Number | K021681 |
| Device Name: | MICROPAQ, MODELS 402, 404 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Contact | Don M Abbey |
| Correspondent | Don M Abbey WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094066784 | K021681 | 000 |