The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Modified Ohmeda Peep Valve (for Gms Absorber).
| Device ID | K881614 |
| 510k Number | K881614 |
| Device Name: | MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Timothy M Davis |
| Correspondent | Timothy M Davis OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-12 |
| Decision Date | 1988-04-29 |