510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914381Substantially Equivalent

Horizon 9000/His Option Amplifier

Mennen Medical, Inc., Clarence NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914381 is the FDA 510(k) clearance record for HORIZON 9000/HIS OPTION AMPLIFIER, a class II device, cleared for Mennen Medical, Inc. on under FDA product code DRR (Amplifier And Signal Conditioner, Biopotential). FDA records list 55 510(k) clearances for Mennen Medical, Inc., from to . As of , FDA records show no recalls naming K914381.

Clearance record

Decision date
Received
(117 days to decision)
Product code
DRR Amplifier And Signal Conditioner, Biopotential
Regulation
21 CFR 870.2050
Device class
Class II
Review panel
Cardiovascular
Applicant
Mennen Medical, Inc. 10123 Main St., Clarence NY
510(k) summary
Statement
Third party review
No

Clearances, product code DRR

Trailing 12 months

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

FDA records show no clearances under product code DRR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRR, 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