The following data is part of a premarket notification filed by Airco/ohio Medical Products with the FDA for Ohio Gms Absorber.
Device ID | K833452 |
510k Number | K833452 |
Device Name: | OHIO GMS ABSORBER |
Classification | Absorber, Carbon-dioxide |
Applicant | AIRCO/OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSF |
CFR Regulation Number | 868.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-23 |
Decision Date | 1983-11-29 |