The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Infant Nasal Cannulae Assembly, Modified.
| Device ID | K911780 |
| 510k Number | K911780 |
| Device Name: | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937009563 | K911780 | 000 |
| 20888937009440 | K911780 | 000 |
| 20888937009457 | K911780 | 000 |
| 20888937009464 | K911780 | 000 |
| 20888937009471 | K911780 | 000 |
| 20888937009488 | K911780 | 000 |
| 20888937009495 | K911780 | 000 |
| 20888937009501 | K911780 | 000 |
| 20888937009518 | K911780 | 000 |
| 20888937009525 | K911780 | 000 |
| 20888937009532 | K911780 | 000 |
| 20888937009549 | K911780 | 000 |
| 20888937009556 | K911780 | 000 |
| 20888937009433 | K911780 | 000 |