The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Cpap System.
| Device ID | K851194 |
| 510k Number | K851194 |
| Device Name: | AMBU CPAP SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | AMBU, INC. 7 OLD SHERMAN TURNPIKE Danbury, CT 06810 |
| Contact | Frank Homa |
| Correspondent | Frank Homa AMBU, INC. 7 OLD SHERMAN TURNPIKE Danbury, CT 06810 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-04-15 |