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FDA 510(k)

REMOTE CONTROL MODULE

K-Number: K851643 · 1985-09-09

ApplicantCircadian, Inc.
Decision Date1985-09-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REMOTE CONTROL MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Circadian, Inc.. It received FDA 510(k) clearance on 1985-09-09 under 510(k) number K851643. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE CONTROL MODULE?

REMOTE CONTROL MODULE is a medical device that received FDA 510(k) clearance on 1985-09-09. The listed applicant is Circadian, Inc.. The 510(k) number is K851643.

When did REMOTE CONTROL MODULE receive FDA 510(k) clearance?

REMOTE CONTROL MODULE received FDA 510(k) clearance on 1985-09-09, under 510(k) number K851643.

Who is the listed applicant for REMOTE CONTROL MODULE?

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 REMOTE CONTROL MODULE?

The FDA product code for REMOTE CONTROL MODULE is DPS.

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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: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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