The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio 7000 Electronic Anesthesia Ventil..
Device ID | K821376 |
510k Number | K821376 |
Device Name: | OHIO 7000 ELECTRONIC ANESTHESIA VENTIL. |
Classification | Ventilator, Continuous, Facility Use |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-10 |
Decision Date | 1982-06-29 |