The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Aespire 7900, Aespire View.
Device ID | K122445 |
510k Number | K122445 |
Device Name: | AESPIRE 7900, AESPIRE VIEW |
Classification | Gas-machine, Anesthesia |
Applicant | DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison, WI 53707 |
Contact | James Raskob |
Correspondent | James Raskob DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR 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 | 2012-08-10 |
Decision Date | 2012-10-12 |
Summary: | summary |