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 | K093716 |
| 510k Number | K093716 |
| 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 | Tom Loescher |
| Correspondent | Tom 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-02 |
| Decision Date | 2010-05-13 |
| Summary: | summary |