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FDA 510(k)

12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200

K-Number: K050074 · 2005-03-22

ApplicantWelch Allyn, Inc.
Decision Date2005-03-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 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 2005-03-22 under 510(k) number K050074. 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 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200?

12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K050074.

When did 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 receive FDA 510(k) clearance?

12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 received FDA 510(k) clearance on 2005-03-22, under 510(k) number K050074.

Who is the listed applicant for 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200?

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 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200?

The FDA product code for 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 is DPS.

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Other records listing Welch Allyn, 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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