The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Monitor, Po2, Intravascular.
| Device ID | K781271 |
| 510k Number | K781271 |
| Device Name: | MONITOR, PO2, INTRAVASCULAR |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | ROCHE MEDICAL ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-24 |
| Decision Date | 1978-10-12 |