The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Co2, Total.
Device ID | K992475 |
510k Number | K992475 |
Device Name: | CARESIDE CO2, TOTAL |
Classification | Enzymatic, Carbon-dioxide |
Applicant | CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
Contact | Kenneth B Asarch |
Correspondent | Kenneth B Asarch CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
Product Code | KHS |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-26 |
Decision Date | 1999-09-15 |
Summary: | summary |