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FDA 510(k)

ANGIOSCAN SPECTRUM ANALYZER

K-Number: K812184 · 1981-09-09

ApplicantUnigon Industries, Inc.
Decision Date1981-09-09
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOSCAN SPECTRUM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Unigon Industries, Inc.. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812184. 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 ANGIOSCAN SPECTRUM ANALYZER?

ANGIOSCAN SPECTRUM ANALYZER is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Unigon Industries, Inc.. The 510(k) number is K812184.

When did ANGIOSCAN SPECTRUM ANALYZER receive FDA 510(k) clearance?

ANGIOSCAN SPECTRUM ANALYZER received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812184.

Who is the listed applicant for ANGIOSCAN SPECTRUM ANALYZER?

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

What is the FDA product code for ANGIOSCAN SPECTRUM ANALYZER?

The FDA product code for ANGIOSCAN SPECTRUM ANALYZER is DXK.

Related Clinical Trials

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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Other records listing Unigon Industries, 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.

K834525ANGIOSCAN FLO MAD SPECTRUM ANALYZERK834501ANGIOSCANE SPECTRUM ANALYZER

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

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

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