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FDA 510(k)

SCANMATE III

K-Number: K921878 · 1992-09-11

ApplicantCircadian, Inc.
Decision Date1992-09-11
Product CodeIYP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANMATE III is the device name listed in this FDA 510(k) record. The listed applicant is Circadian, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K921878. The device is classified under product code IYP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANMATE III?

SCANMATE III is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Circadian, Inc.. The 510(k) number is K921878.

When did SCANMATE III receive FDA 510(k) clearance?

SCANMATE III received FDA 510(k) clearance on 1992-09-11, under 510(k) number K921878.

Who is the listed applicant for SCANMATE III?

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 SCANMATE III?

The FDA product code for SCANMATE III is IYP.

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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.

K894956CIRCAMED HOLTER VERSION 4K874641CIRCADIAN STRESS TEST IIK874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERK871251CIRCAMED FULL DISCLOSURE SYSTEMK860973CIRCADIAN STRESS TEST SYSTEMK851517CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO

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Related Devices (Code: IYP)

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.

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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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