The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Nasal Cpap Mask.
| Device ID | K972605 |
| 510k Number | K972605 |
| Device Name: | EMS NASAL CPAP MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Contact | Bonnie Holly |
| Correspondent | Bonnie Holly ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1998-01-28 |
| Summary: | summary |