The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Cpap Infant Nasal Cannulae Set.
| Device ID | K823936 |
| 510k Number | K823936 |
| Device Name: | CPAP INFANT NASAL CANNULAE SET |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ACKRAD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-29 |
| Decision Date | 1983-01-28 |