The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Ppm Iii.
Device ID | K940712 |
510k Number | K940712 |
Device Name: | PPM III |
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 | 1994-02-17 |
Decision Date | 1994-11-14 |