The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Bio-tek Percent Oxygen Monitor 74222.
Device ID | K831522 |
510k Number | K831522 |
Device Name: | BIO-TEK PERCENT OXYGEN MONITOR 74222 |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | BIO-TEK INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-12 |
Decision Date | 1983-09-12 |