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FDA 510(k)

CIRCAMED I

K-Number: K800214 · 1980-02-29

ApplicantCircadian, Inc.
Decision Date1980-02-29
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCAMED I is the device name listed in this FDA 510(k) record. The listed applicant is Circadian, Inc.. It received FDA 510(k) clearance on 1980-02-29 under 510(k) number K800214. 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 CIRCAMED I?

CIRCAMED I is a medical device that received FDA 510(k) clearance on 1980-02-29. The listed applicant is Circadian, Inc.. The 510(k) number is K800214.

When did CIRCAMED I receive FDA 510(k) clearance?

CIRCAMED I received FDA 510(k) clearance on 1980-02-29, under 510(k) number K800214.

Who is the listed applicant for CIRCAMED I?

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

What is the FDA product code for CIRCAMED I?

The FDA product code for CIRCAMED I is DSH.

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Other records listing Circadian, 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.

K921878SCANMATE IIIK894956CIRCAMED HOLTER VERSION 4K874641CIRCADIAN STRESS TEST IIK874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERK871251CIRCAMED FULL DISCLOSURE SYSTEMK860973CIRCADIAN STRESS TEST SYSTEM

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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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