The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Besmed Peak Flow Meter.
| Device ID | K172804 |
| 510k Number | K172804 |
| Device Name: | Besmed Peak Flow Meter |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | Besmed Health Business Corp. No.5, Lane 116, Wu-Kong 2nd Rd Wu-ku District, TW |
| Contact | Lawrence Wu |
| Correspondent | Paul Dryden Besmed Health Business Corp. No.5, Lane 116, Wu-Kong 2nd Rd Wu-ku District, TW |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716770292007 | K172804 | 000 |
| 04716770291000 | K172804 | 000 |
| 00850002860382 | K172804 | 000 |
| 00840117318793 | K172804 | 000 |
| 00840117318786 | K172804 | 000 |