The following data is part of a premarket notification filed by Medical Acoustics with the FDA for Lung Flute Therapeutic.
| Device ID | K091557 |
| 510k Number | K091557 |
| Device Name: | LUNG FLUTE THERAPEUTIC |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | MEDICAL ACOUSTICS 255 GREAT ARROW AVE. STE 23 Buffalo, NY 14207 |
| Contact | Nicolaas J Smit |
| Correspondent | Nicolaas J Smit MEDICAL ACOUSTICS 255 GREAT ARROW AVE. STE 23 Buffalo, NY 14207 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2010-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816133010083 | K091557 | 000 |
| 20816133010014 | K091557 | 000 |