The following data is part of a premarket notification filed by Invivo Research Labs, Inc. with the FDA for Invivo Pulse Oximeter, Model 4500.
| Device ID | K864730 |
| 510k Number | K864730 |
| Device Name: | INVIVO PULSE OXIMETER, MODEL 4500 |
| Classification | Oximeter |
| Applicant | INVIVO RESEARCH LABS, INC. 3061 W. ALBANY ST. Tulsa, OK 74012 |
| Contact | Roger Susi |
| Correspondent | Roger Susi INVIVO RESEARCH LABS, INC. 3061 W. ALBANY ST. Tulsa, OK 74012 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-04 |
| Decision Date | 1987-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838051522 | K864730 | 000 |