510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K862200Substantially Equivalent

Fortec Mi-100, Blood Pressure Meter

Fortec Electronic Corp./Nam Tai, Mississauga, Ont., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862200 is the FDA 510(k) clearance record for FORTEC MI-100, BLOOD PRESSURE METER, a class II device, cleared for Fortec Electronic Corp./Nam Tai on under FDA product code DSK (Computer, Blood-Pressure). FDA records list one 510(k) clearance for Fortec Electronic Corp./Nam Tai. As of , FDA records show no recalls naming K862200.

Clearance record

Decision date
Received
(161 days to decision)
Product code
DSK Computer, Blood-Pressure
Regulation
21 CFR 870.1110
Device class
Class II
Review panel
Cardiovascular
Applicant
Fortec Electronic Corp./Nam Tai 855 Matheson Blvd. E. Unit 4, Mississauga, Ont., CA
Third party review
No

Clearances, product code DSK

Trailing 12 months

FDA records hold no clearances under product code DSK in the trailing twelve months.

FDA records show no clearances under product code DSK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260