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FDA 510(k)

ATHANS EKG STANDARDIZER

K-Number: K903671 · 1991-01-03

ApplicantAdvanced Medical Concepts, Inc.
Decision Date1991-01-03
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATHANS EKG STANDARDIZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Concepts, Inc.. It received FDA 510(k) clearance on 1991-01-03 under 510(k) number K903671. 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 ATHANS EKG STANDARDIZER?

ATHANS EKG STANDARDIZER is a medical device that received FDA 510(k) clearance on 1991-01-03. The listed applicant is Advanced Medical Concepts, Inc.. The 510(k) number is K903671.

When did ATHANS EKG STANDARDIZER receive FDA 510(k) clearance?

ATHANS EKG STANDARDIZER received FDA 510(k) clearance on 1991-01-03, under 510(k) number K903671.

Who is the listed applicant for ATHANS EKG STANDARDIZER?

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

What is the FDA product code for ATHANS EKG STANDARDIZER?

The FDA product code for ATHANS EKG STANDARDIZER is DPS.

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Other records listing Advanced Medical Concepts, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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