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 |