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FDA 510(k)

ELECTROCARDIOGRAPH-ECG CALIPER

K-Number: K850021 · 1985-02-08

ApplicantDevcom, Inc.
Decision Date1985-02-08
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH-ECG CALIPER is the device name listed in this FDA 510(k) record. The listed applicant is Devcom, Inc.. It received FDA 510(k) clearance on 1985-02-08 under 510(k) number K850021. 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 ELECTROCARDIOGRAPH-ECG CALIPER?

ELECTROCARDIOGRAPH-ECG CALIPER is a medical device that received FDA 510(k) clearance on 1985-02-08. The listed applicant is Devcom, Inc.. The 510(k) number is K850021.

When did ELECTROCARDIOGRAPH-ECG CALIPER receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH-ECG CALIPER received FDA 510(k) clearance on 1985-02-08, under 510(k) number K850021.

Who is the listed applicant for ELECTROCARDIOGRAPH-ECG CALIPER?

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

What is the FDA product code for ELECTROCARDIOGRAPH-ECG CALIPER?

The FDA product code for ELECTROCARDIOGRAPH-ECG CALIPER is DPS.

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Other records listing Devcom, 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.

K902378CARDIOTHORACIC RULERK874233BLOOD PRESSURE SLEEVE W/TUBINGK863313GRIP STRENGTH DEVICE (GSD)K861264JOINT MEASUREMENT INDICATORK861043SPINAL EXCURSION METER

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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