The following data is part of a premarket notification filed by Norco, Inc. with the FDA for Lung Diffusion Gas Mixtures.
Device ID | K911471 |
510k Number | K911471 |
Device Name: | LUNG DIFFUSION GAS MIXTURES |
Classification | Gas, Calibration (specified Concentration) |
Applicant | NORCO, INC. 1121 WEST AMITY Boise, ID 83705 |
Contact | Lyle R Feely |
Correspondent | Lyle R Feely NORCO, INC. 1121 WEST AMITY Boise, ID 83705 |
Product Code | BXK |
CFR Regulation Number | 868.6400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-03 |
Decision Date | 1991-06-18 |