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FDA 510(k)

CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO

K-Number: K851517 · 1985-10-02

ApplicantCircadian, Inc.
Decision Date1985-10-02
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO is the device name listed in this FDA 510(k) record. The listed applicant is Circadian, Inc.. It received FDA 510(k) clearance on 1985-10-02 under 510(k) number K851517. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO?

CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO is a medical device that received FDA 510(k) clearance on 1985-10-02. The listed applicant is Circadian, Inc.. The 510(k) number is K851517.

When did CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO receive FDA 510(k) clearance?

CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO received FDA 510(k) clearance on 1985-10-02, under 510(k) number K851517.

Who is the listed applicant for CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO?

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 CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO?

The FDA product code for CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO is DSI.

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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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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