The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Positive End Expiratory Pressure Valve.
| Device ID | K802943 |
| 510k Number | K802943 |
| Device Name: | POSITIVE END EXPIRATORY PRESSURE VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | FRASER HARLAKE, INC. 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 | 1980-11-19 |
| Decision Date | 1981-01-15 |