The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Modification To Engineered Medical Systems Disposable Manual Resuscitator With Co2 Detection.
| Device ID | K991955 |
| 510k Number | K991955 |
| Device Name: | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. Indianapolis, IN 46241 |
| Contact | Bonnie Holly |
| Correspondent | Bonnie Holly ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. Indianapolis, IN 46241 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-07-06 |
| Summary: | summary |