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FDA 510(k)

CARDIOCASSETTE II #363

K-Number: K821453 · 1982-05-25

ApplicantBirtcher Corp.
Decision Date1982-05-25
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCASSETTE II #363 is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1982-05-25 under 510(k) number K821453. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCASSETTE II #363?

CARDIOCASSETTE II #363 is a medical device that received FDA 510(k) clearance on 1982-05-25. The listed applicant is Birtcher Corp.. The 510(k) number is K821453.

When did CARDIOCASSETTE II #363 receive FDA 510(k) clearance?

CARDIOCASSETTE II #363 received FDA 510(k) clearance on 1982-05-25, under 510(k) number K821453.

Who is the listed applicant for CARDIOCASSETTE II #363?

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

What is the FDA product code for CARDIOCASSETTE II #363?

The FDA product code for CARDIOCASSETTE II #363 is DSH.

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Other records listing Birtcher Corp. as applicant

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K881328MODEL 375 ECGK860687BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768K860718ELECTROSURGERY PENCIL, MODEL 767K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33K854864BI-POLAR FORCEPSK850943MODEL 775 BIPOLAR COAGULATOR

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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