The following data is part of a premarket notification filed by A Plus Medical with the FDA for Babi Plus Neonatal Resuscitation Bag.
| Device ID | K112852 |
| 510k Number | K112852 |
| Device Name: | BABI PLUS NEONATAL RESUSCITATION BAG |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-18 |
| Decision Date | 2012-01-13 |
| Summary: | summary |