510(k) K831033

GIREX by Lancer Assoc. — Product Code ION

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1983
Date Received
March 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Non-Measuring
Device Class
Class I
Regulation Number
890.5370
Review Panel
PM
Submission Type