The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Ecg Analysis System.
Device ID | K962930 |
510k Number | K962930 |
Device Name: | SPACELABS MEDICAL ECG ANALYSIS SYSTEM |
Classification | Computer, Diagnostic, Programmable |
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 | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-29 |
Decision Date | 1997-04-25 |
Summary: | summary |