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Fortec Mi-100, Blood Pressure Meter

by Fortec Electronic Corp./Nam Tai 510(k)

Active United States

510(k) K862200

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862200 Date18 Nov 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSK
Device Class
Class II
Regulation
21 CFR Part 870.1110
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent