The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Ari Standard Anesthesia Record.
Device ID | K854213 |
510k Number | K854213 |
Device Name: | ARI STANDARD ANESTHESIA RECORD |
Classification | Gas-machine, Anesthesia |
Applicant | AGILENT TECHNOLOGIES, INC. 1500 OLIVER BUILDING Pittsburgh, PA 15222 |
Contact | Edward Weisgerber |
Correspondent | Edward Weisgerber AGILENT TECHNOLOGIES, INC. 1500 OLIVER BUILDING Pittsburgh, PA 15222 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-17 |
Decision Date | 1985-12-19 |