The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Spo2 Option.
| Device ID | K902730 |
| 510k Number | K902730 |
| Device Name: | SPO2 OPTION |
| Classification | Oximeter |
| Applicant | PROTOCOL SYSTEMS, INC. 14924 N.W. GREENBRIER PKWY. Beaverton, OR 97006 |
| Contact | James Sandberg |
| Correspondent | James Sandberg PROTOCOL SYSTEMS, INC. 14924 N.W. GREENBRIER PKWY. Beaverton, OR 97006 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-21 |
| Decision Date | 1990-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094075298 | K902730 | 000 |
| 00732094199345 | K902730 | 000 |
| 00732094034608 | K902730 | 000 |
| 00732094032512 | K902730 | 000 |
| 00732094079302 | K902730 | 000 |
| 00732094079166 | K902730 | 000 |
| 00732094079081 | K902730 | 000 |
| 00732094079067 | K902730 | 000 |
| 00732094079050 | K902730 | 000 |