The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Acoustic Rhinometer.
Device ID | K921452 |
510k Number | K921452 |
Device Name: | ACOUSTIC RHINOMETER |
Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
Contact | Lewis H Martin |
Correspondent | Lewis H Martin HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
Product Code | BXQ |
CFR Regulation Number | 868.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-26 |
Decision Date | 1993-07-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860719000308 | K921452 | 000 |