The following data is part of a premarket notification filed by And/or Corp. with the FDA for Rhinomanometers Nr3, Nr4.
Device ID | K851143 |
510k Number | K851143 |
Device Name: | RHINOMANOMETERS NR3, NR4 |
Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
Applicant | AND/OR CORP. 2801 YOUNGFIELD, SUITE 110 Golden, CO 80401 |
Contact | Charlie D Anderson |
Correspondent | Charlie D Anderson AND/OR CORP. 2801 YOUNGFIELD, SUITE 110 Golden, CO 80401 |
Product Code | BXQ |
CFR Regulation Number | 868.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-21 |
Decision Date | 1985-05-23 |