The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Genesis Bls.
| Device ID | K983643 |
| 510k Number | K983643 |
| Device Name: | GENESIS BLS |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Contact | Kevin Bowden |
| Correspondent | Kevin Bowden 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-16 |
| Decision Date | 1998-10-29 |
| Summary: | summary |