The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Cpr Bio-barrier Facesheild.
| Device ID | K960995 |
| 510k Number | K960995 |
| Device Name: | CPR BIO-BARRIER FACESHEILD |
| Classification | Valve, Non-rebreathing |
| Applicant | O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA Ontario L5s 1c8, CA |
| Contact | Kevin Bowden |
| Correspondent | Kevin Bowden O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA Ontario L5s 1c8, CA |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-12 |
| Decision Date | 1997-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540195056029 | K960995 | 000 |