The following data is part of a premarket notification filed by A Plus Medical with the FDA for Ventiplus Disposable Manometer 0-60 Cm H2o; Ventiplus Disposable Manometer 0-20 Cm H2o; Ventiplus Disposable Manometer 0.
| Device ID | K102377 |
| 510k Number | K102377 |
| Device Name: | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| 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 | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540195037004 | K102377 | 000 |
| 44710810100305 | K102377 | 000 |