510(k) K955357

OLYMPIC SMART SCALE MODEL 50/50RA by Olympic Medical Corp. — Product Code FRW

K955357 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC SMART SCALE MODEL 50/50RA". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
October 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Patient
Device Class
Class I
Regulation Number
880.2720
Review Panel
HO
Submission Type