The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Ear Oximeter.
| Device ID | K810363 |
| 510k Number | K810363 |
| Device Name: | EAR OXIMETER |
| Classification | Oximeter, Ear |
| Applicant | BIO-TEK INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DPZ |
| CFR Regulation Number | 870.2710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-11 |
| Decision Date | 1981-02-27 |