The following data is part of a premarket notification filed by Mindray Ds Usa, Inc. with the FDA for As3700 Anesthsia Delivery System.
Device ID | K102471 |
510k Number | K102471 |
Device Name: | AS3700 ANESTHSIA DELIVERY SYSTEM |
Classification | Gas-machine, Anesthesia |
Applicant | MINDRAY DS USA, INC. 800 MACARTHUR BLVD Mahwah, NJ 07430 |
Contact | Russell Olsen |
Correspondent | Russell Olsen MINDRAY DS USA, INC. 800 MACARTHUR BLVD Mahwah, NJ 07430 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-30 |
Decision Date | 2011-02-11 |
Summary: | summary |