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FDA 510(k)

KENZ-ECG 102

K-Number: K863965 · 1986-12-22

ApplicantCompumed, Inc.
Decision Date1986-12-22
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENZ-ECG 102 is the device name listed in this FDA 510(k) record. The listed applicant is Compumed, Inc.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K863965. 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 KENZ-ECG 102?

KENZ-ECG 102 is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Compumed, Inc.. The 510(k) number is K863965.

When did KENZ-ECG 102 receive FDA 510(k) clearance?

KENZ-ECG 102 received FDA 510(k) clearance on 1986-12-22, under 510(k) number K863965.

Who is the listed applicant for KENZ-ECG 102?

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

What is the FDA product code for KENZ-ECG 102?

The FDA product code for KENZ-ECG 102 is DXK.

Other records listing Compumed, 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.

K984285OSTEOGRAM BONE DENSITOMETERK955708COMPUMED DICON CLIENTK854626COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307BK802272COMPUTER ECG TERMINALK771648COMPUTER ECG TERMINAL

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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