The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Aestiva/5 Mri Anesthesia System.
Device ID | K050055 |
510k Number | K050055 |
Device Name: | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM |
Classification | Gas-machine, Anesthesia |
Applicant | DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 |
Contact | Dan Kosednar |
Correspondent | Dan Kosednar DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-11 |
Decision Date | 2005-02-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682102339 | K050055 | 000 |