The following data is part of a premarket notification filed by Mckesson Technologies Inc. with the FDA for Mckesson Anesthesia Care.
Device ID | K113633 |
510k Number | K113633 |
Device Name: | MCKESSON ANESTHESIA CARE |
Classification | Gas-machine, Anesthesia |
Applicant | MCKESSON TECHNOLOGIES INC. 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
Contact | Janice M Hogan |
Correspondent | Janice M Hogan MCKESSON TECHNOLOGIES INC. 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-08 |
Decision Date | 2012-04-20 |