The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Monitor, Sensomatiii Oxygen.
| Device ID | K781910 |
| 510k Number | K781910 |
| Device Name: | MONITOR, SENSOMATIII OXYGEN |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | BIOCHEM INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-14 |
| Decision Date | 1978-12-26 |