The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Mouth To Mask Resuscitators.
| Device ID | K983919 |
| 510k Number | K983919 |
| Device Name: | EMS MOUTH TO MASK RESUSCITATORS |
| Classification | Valve, Non-rebreathing |
| 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 | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-04 |
| Decision Date | 1999-04-07 |
| Summary: | summary |