The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Modified Infant Nasal Cannulae Assembly.
| Device ID | K895031 |
| 510k Number | K895031 |
| Device Name: | MODIFIED INFANT NASAL CANNULAE ASSEMBLY |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-10-30 |