The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Micro Span Transcutaneous Oxygen Monit.
| Device ID | K840918 |
| 510k Number | K840918 |
| Device Name: | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | BIOCHEM INTERNATIONAL, INC. 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 | 1984-03-01 |
| Decision Date | 1984-04-17 |