The following data is part of a premarket notification filed by Medical Acoustics Llc with the FDA for Lung Flute.
Device ID | K060439 |
510k Number | K060439 |
Device Name: | LUNG FLUTE |
Classification | Percussor, Powered-electric |
Applicant | MEDICAL ACOUSTICS LLC 255 GREAT ARROW AVE., SUITE 23 Buffalo, NY 14207 |
Contact | Nicolaas J Smit |
Correspondent | Nicolaas J Smit MEDICAL ACOUSTICS LLC 255 GREAT ARROW AVE., SUITE 23 Buffalo, NY 14207 |
Product Code | BYI |
CFR Regulation Number | 868.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-21 |
Decision Date | 2006-06-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20816133010007 | K060439 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUNG FLUTE 97086949 not registered Live/Pending |
Acoustic Innovations LLC 2021-10-21 |
LUNG FLUTE 86177725 4612904 Live/Registered |
Medical Acoustics, LLC 2014-01-28 |
LUNG FLUTE 78171154 2830865 Dead/Cancelled |
Medical Acoustics, LLC 2002-10-04 |