The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Pediatric C.p.a.p. System.
| Device ID | K880161 |
| 510k Number | K880161 |
| Device Name: | ACKRAD PEDIATRIC C.P.A.P. SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman,phd |
| Correspondent | Bernard Ackerman,phd ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-03-04 |