The following data is part of a premarket notification filed by Besmed Health Business Corporation with the FDA for Volumetric Incentive Spirometer.
| Device ID | K141355 |
| 510k Number | K141355 |
| Device Name: | VOLUMETRIC INCENTIVE SPIROMETER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | BESMED HEALTH BUSINESS CORPORATION No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District New Taipei City, TW 24888 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden BESMED HEALTH BUSINESS CORPORATION No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District New Taipei City, TW 24888 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716770935003 | K141355 | 000 |
| 04716770932507 | K141355 | 000 |
| 00840117318199 | K141355 | 000 |
| 00840117318182 | K141355 | 000 |
| 00840117320819 | K141355 | 000 |
| 20888277409153 | K141355 | 000 |
| 20888277409146 | K141355 | 000 |