The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Transcutaneous Oxygen Perfusion Monitor.
| Device ID | K780458 |
| 510k Number | K780458 |
| Device Name: | TRANSCUTANEOUS OXYGEN PERFUSION MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | NARCO AIR-SHIELDS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-23 |
| Decision Date | 1978-10-10 |