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FDA 510(k)

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

K-Number: K896437 · 1990-12-03

ApplicantKontron Instruments, Inc.
Decision Date1990-12-03
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING 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 1990-12-03 under 510(k) number K896437. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM?

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K896437.

When did KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1990-12-03, under 510(k) number K896437.

Who is the listed applicant for KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING 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 44 HVCD ULTRASOUND IMAGING SYSTEM?

The FDA product code for KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM is DPT.

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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.

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Related Devices (Code: DPT)

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.

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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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