The following data is part of a premarket notification filed by A Plus Medical with the FDA for Babi Plus Infant Nasal Cannula System.
| Device ID | K110471 |
| 510k Number | K110471 |
| Device Name: | BABI PLUS INFANT NASAL CANNULA SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G Carlsbad, CA 92008 |
| Contact | Thomas C Loescher |
| Correspondent | Thomas C Loescher A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G Carlsbad, CA 92008 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-18 |
| Decision Date | 2011-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810117525 | K110471 | 000 |