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FDA 510(k)

CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS

K-Number: K072449 · 2007-11-29

ApplicantWelch Allyn, Inc.
Decision Date2007-11-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2007-11-29 under 510(k) number K072449. 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 CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS?

CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS is a medical device that received FDA 510(k) clearance on 2007-11-29. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K072449.

When did CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS receive FDA 510(k) clearance?

CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS received FDA 510(k) clearance on 2007-11-29, under 510(k) number K072449.

Who is the listed applicant for CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS?

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

What is the FDA product code for CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS?

The FDA product code for CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS is DPS.

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Other records listing Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

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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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