The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90201 Holter Recorder.
Device ID | K844940 |
510k Number | K844940 |
Device Name: | SPACELABS MODEL 90201 HOLTER RECORDER |
Classification | Recorder, Magnetic Tape, Medical |
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 | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-20 |
Decision Date | 1985-02-14 |