510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875334Substantially Equivalent

Kontron Sigma 1 Digital Echocardiograph System

Kontron Instruments, Inc., Everett MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875334 is the FDA 510(k) clearance record for KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM, a class II device, cleared for Kontron Instruments, Inc. on under FDA product code HGL (Transducer, Ultrasonic, Obstetric). FDA records list 58 510(k) clearances for Kontron Instruments, Inc., from to . As of , FDA records show no recalls naming K875334.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HGL Transducer, Ultrasonic, Obstetric
Regulation
21 CFR 884.2960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kontron Instruments, Inc. 9 Plymouth St., Everett MA
Third party review
No

Clearances, product code HGL

Trailing 12 months

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

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