The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Single Use Manual Resuscitator Peep Valve.
| Device ID | K932799 |
| 510k Number | K932799 |
| Device Name: | SINGLE USE MANUAL RESUSCITATOR PEEP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Contact | Jeff Quinn |
| Correspondent | Jeff Quinn ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-09-03 |