The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Flynn Series Iii Bag/mask Unit-.
Device ID | K832495 |
510k Number | K832495 |
Device Name: | FLYNN SERIES III BAG/MASK UNIT- |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | O-TWO SYSTEMS INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-27 |
Decision Date | 1983-09-29 |