510(k) K020399

RESPERATE; MODEL RR-150 by Intercure , Ltd. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
February 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type