The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Disposable Pressure Manometer.
| Device ID | K140370 |
| 510k Number | K140370 |
| Device Name: | DISPOSABLE PRESSURE MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, Wu-ku District, TW Tw |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, Wu-ku District, TW Tw |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716770214665 | K140370 | 000 |
| 04716770214641 | K140370 | 000 |
| 04716770214603 | K140370 | 000 |
| 04716770214566 | K140370 | 000 |
| 04716770214542 | K140370 | 000 |
| 04716770214504 | K140370 | 000 |