The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Excel 3000 Anesthesia System.
Device ID | K973896 |
510k Number | K973896 |
Device Name: | OHMEDA EXCEL 3000 ANESTHESIA SYSTEM |
Classification | Gas-machine, Anesthesia |
Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | Charles Morreale |
Correspondent | Charles Morreale OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-14 |
Decision Date | 1998-04-21 |
Summary: | summary |