The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs-general System Link.
Device ID | K850627 |
510k Number | K850627 |
Device Name: | SPACELABS-GENERAL SYSTEM LINK |
Classification | Computer, Diagnostic, Programmable |
Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
Contact | Allen M Hans |
Correspondent | Allen M Hans SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-19 |
Decision Date | 1985-05-28 |