The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Multi-disclosure Workstation.
Device ID | K962811 |
510k Number | K962811 |
Device Name: | SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION |
Classification | Display, Cathode-ray Tube, Medical |
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 | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-18 |
Decision Date | 1997-06-24 |
Summary: | summary |