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FDA 510(k)

FASTRACE III, ECG ELECTRODE

K-Number: K860636 · 1986-05-09

ApplicantAndover Medical, Inc.
Decision Date1986-05-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FASTRACE III, ECG ELECTRODE 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 1986-05-09 under 510(k) number K860636. 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 FASTRACE III, ECG ELECTRODE?

FASTRACE III, ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is Andover Medical, Inc.. The 510(k) number is K860636.

When did FASTRACE III, ECG ELECTRODE receive FDA 510(k) clearance?

FASTRACE III, ECG ELECTRODE received FDA 510(k) clearance on 1986-05-09, under 510(k) number K860636.

Who is the listed applicant for FASTRACE III, ECG ELECTRODE?

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 FASTRACE III, ECG ELECTRODE?

The FDA product code for FASTRACE III, ECG ELECTRODE is DPS.

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Other records listing Andover Medical, Inc. as applicant

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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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