The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Bag-to-ventilator Selector Valve.
Device ID | K841274 |
510k Number | K841274 |
Device Name: | BAG-TO-VENTILATOR SELECTOR VALVE |
Classification | Gas-machine, Anesthesia |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-27 |
Decision Date | 1984-04-13 |