510(k) K920423

OLYMPIC SMART SCALE CARE CENTER by Olympic Medical Corp. — Product Code FEW

K920423 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC SMART SCALE CARE CENTER". The FDA issued a decision of Substantially Equivalent on June 11, 1992. The device falls under product code FEW (Catheter, Malecot), a Class II device regulated under 21 CFR 876.5090. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
January 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Malecot
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type