The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Peep/cpap Valve.
| Device ID | K781332 |
| 510k Number | K781332 |
| Device Name: | PEEP/CPAP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-02 |
| Decision Date | 1978-10-04 |