The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Pyramis Ecg Management System Model Numbers, 92600 And 92601.
| Device ID | K032038 |
| 510k Number | K032038 |
| Device Name: | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | Karen Browne |
| Correspondent | Karen Browne QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-01 |
| Decision Date | 2003-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345029994 | K032038 | 000 |
| 00812345029970 | K032038 | 000 |
| 00812345029802 | K032038 | 000 |
| 00812345024784 | K032038 | 000 |
| 00732094315318 | K032038 | 000 |
| 00732094272338 | K032038 | 000 |
| 00732094261332 | K032038 | 000 |