Kontron Defibrillator 7501

by Kontron Instruments, Inc. 510(k)

Active United States

510(k) K854307

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK854307	Date4 Dec 1985Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
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: K854307
FDA Product Code: LDD

Device Class: Class II
Regulation: 21 CFR Part 870.5300
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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