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FDA 510(k)

KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM

K-Number: K852543 · 1985-09-20

ApplicantKontron Instruments, Inc.
Decision Date1985-09-20
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K852543. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM?

KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K852543.

When did KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM receive FDA 510(k) clearance?

KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM received FDA 510(k) clearance on 1985-09-20, under 510(k) number K852543.

Who is the listed applicant for KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM?

The FDA 510(k) record lists Kontron Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM?

The FDA product code for KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM is DXK.

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Other records listing Kontron Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSK925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSK923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONK905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

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Related Devices (Code: DXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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