510(k) K922839

MID-CANADA MEDICAL by Mid-Canada Medical — Product Code IMI

K922839 is an FDA 510(k) premarket notification submitted by Mid-Canada Medical for the device "MID-CANADA MEDICAL". The FDA issued a decision of Substantially Equivalent on July 2, 1993. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Mid-Canada Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1993
Date Received
June 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type