The following data is part of a premarket notification filed by Bio-nustics, Inc. with the FDA for Control 282.
| Device ID | K832066 |
| 510k Number | K832066 |
| Device Name: | CONTROL 282 |
| Classification | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide |
| Applicant | BIO-NUSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-27 |
| Decision Date | 1983-09-29 |