The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Fllynn(r) Genesis Ac.
Device ID | K913039 |
510k Number | K913039 |
Device Name: | FLLYNN(R) GENESIS AC |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
Contact | Joe Lassaline |
Correspondent | Joe Lassaline O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
Product Code | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-09 |
Decision Date | 1992-08-25 |