The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Anesthesia Delivery System (ads) With Pressure Control Mode.
Device ID | K003663 |
510k Number | K003663 |
Device Name: | SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE |
Classification | Gas-machine, Anesthesia |
Applicant | SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Contact | Irene Jaworski |
Correspondent | Irene Jaworski SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-28 |
Decision Date | 2001-06-28 |