510(k) K001369

RESPIEVENTS, VERSION 4.2 by Non-Invasive Monitoring Systems, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2000
Date Received
May 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type