The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Flynn Iii-child Bag-mask Unit Etc.
Device ID | K834400 |
510k Number | K834400 |
Device Name: | FLYNN III-CHILD BAG-MASK UNIT ETC |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | O-TWO SYSTEMS INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-14 |
Decision Date | 1984-01-13 |