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 |