The following data is part of a premarket notification filed by Norco, Inc. with the FDA for Clinical Blood Gas Mixtures.
Device ID | K904163 |
510k Number | K904163 |
Device Name: | CLINICAL BLOOD GAS MIXTURES |
Classification | Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical |
Applicant | NORCO, INC. 1121 WEST AMITY Boise, ID 83705 |
Contact | Lyle Feely |
Correspondent | Lyle Feely NORCO, INC. 1121 WEST AMITY Boise, ID 83705 |
Product Code | LCH |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-11 |
Decision Date | 1990-11-01 |