510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935832Substantially Equivalent

Chromophare

Berchtold Holding GmbH, Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935832 is the FDA 510(k) clearance record for CHROMOPHARE, a class I device, cleared for Berchtold Holding GmbH on under FDA product code KZF (Device, Medical Examination, Ac Powered). FDA records list 16 510(k) clearances for Berchtold Holding GmbH, from to . As of , FDA records show no recalls naming K935832.

Clearance record

Decision date
Received
(58 days to decision)
Product code
KZF Device, Medical Examination, Ac Powered
Regulation
21 CFR 880.6320
Device class
Class I
Review panel
General Hospital
Applicant
Berchtold Holding GmbH Ludwigstaler St. 25, Tuttlingen, DE
510(k) summary
Statement
Third party review
No

Clearances, product code KZF

Trailing 12 months

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

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