510(k) K870300

BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 by Belmont Equipment Corp. — Product Code KPR

K870300 is an FDA 510(k) premarket notification submitted by Belmont Equipment Corp. for the device "BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Belmont Equipment Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
January 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type