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FDA 510(k)

HOLTER KIT MODEL #5000 SERIES

K-Number: K823414 · 1982-12-30

ApplicantAndover Medical, Inc.
Decision Date1982-12-30
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER KIT MODEL #5000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823414. 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 HOLTER KIT MODEL #5000 SERIES?

HOLTER KIT MODEL #5000 SERIES is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Andover Medical, Inc.. The 510(k) number is K823414.

When did HOLTER KIT MODEL #5000 SERIES receive FDA 510(k) clearance?

HOLTER KIT MODEL #5000 SERIES received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823414.

Who is the listed applicant for HOLTER KIT MODEL #5000 SERIES?

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

What is the FDA product code for HOLTER KIT MODEL #5000 SERIES?

The FDA product code for HOLTER KIT MODEL #5000 SERIES is DSH.

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Other records listing Andover Medical, Inc. as applicant

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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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