510(k) K001056

OLYMPIC WARM-UP by Olympic Medical Corp. — Product Code ILY

K001056 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC WARM-UP". The FDA issued a decision of Substantially Equivalent on September 29, 2000. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2000
Date Received
April 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type