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FDA 510(k)

CARDIOCAP DR-124 RECORDER

K-Number: K910620 · 1991-05-07

ApplicantDatex Division Instrumentarium Corp.
Decision Date1991-05-07
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCAP DR-124 RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1991-05-07 under 510(k) number K910620. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCAP DR-124 RECORDER?

CARDIOCAP DR-124 RECORDER is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K910620.

When did CARDIOCAP DR-124 RECORDER receive FDA 510(k) clearance?

CARDIOCAP DR-124 RECORDER received FDA 510(k) clearance on 1991-05-07, under 510(k) number K910620.

Who is the listed applicant for CARDIOCAP DR-124 RECORDER?

The FDA 510(k) record lists Datex Division Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOCAP DR-124 RECORDER?

The FDA product code for CARDIOCAP DR-124 RECORDER is DRG.

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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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