The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Triball Incentive Spirometer.
| Device ID | K133873 |
| 510k Number | K133873 |
| Device Name: | TRIBALL INCENTIVE SPIROMETER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, Wu-ku District, TW Taiwan |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, Wu-ku District, TW Taiwan |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716770931005 | K133873 | 000 |
| 04716770342108 | K133873 | 000 |