The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical 90519 Anesthesia Delivery System.
| Device ID | K981530 |
| 510k Number | K981530 |
| Device Name: | SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Russ Garrison |
| Correspondent | Russ Garrison 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 | 1998-04-29 |
| Decision Date | 1998-11-20 |
| Summary: | summary |