The following data is part of a premarket notification filed by A Plus Medical with the FDA for Babi*plus Bubble Pap Valve.
| Device ID | K090317 |
| 510k Number | K090317 |
| Device Name: | BABI*PLUS BUBBLE PAP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| 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 | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-09 |
| Decision Date | 2009-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810093577 | K090317 | 000 |
| 00856825003159 | K090317 | 000 |
| 00856825003166 | K090317 | 000 |
| 00856825003197 | K090317 | 000 |
| 00856825003203 | K090317 | 000 |
| 44710810093560 | K090317 | 000 |
| 04710810105265 | K090317 | 000 |
| 44710810093553 | K090317 | 000 |
| 04710810093579 | K090317 | 000 |
| 44710810100794 | K090317 | 000 |
| 44710810117464 | K090317 | 000 |