The following data is part of a premarket notification filed by A Plus Medical with the FDA for Venti.plus Hyperinflation Bag System With Pressure Manometer.
| Device ID | K092687 |
| 510k Number | K092687 |
| Device Name: | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G Carlsbad, CA 92008 |
| Contact | Thomas Loescher |
| Correspondent | Thomas Loescher A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G Carlsbad, CA 92008 |
| Product Code | NHK |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-01 |
| Decision Date | 2009-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810117396 | K092687 | 000 |
| 44710810100275 | K092687 | 000 |
| 44710810100282 | K092687 | 000 |
| 44710810100299 | K092687 | 000 |
| 44710810100480 | K092687 | 000 |
| 44710810100497 | K092687 | 000 |
| 44710810100503 | K092687 | 000 |
| 44710810117372 | K092687 | 000 |
| 44710810117389 | K092687 | 000 |
| 44710810100268 | K092687 | 000 |