The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Biomedical Sensors-shiley Bgm 4000 Intra Blood Gas.
Device ID | K901548 |
510k Number | K901548 |
Device Name: | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS |
Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Abati, Phd |
Correspondent | Abati, Phd SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Product Code | CCC |
CFR Regulation Number | 868.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-03 |
Decision Date | 1991-01-14 |