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FDA 510(k)

CP150 ELECTROCARDIOGRAPH

K-Number: K131573 · 2013-07-03

ApplicantWelch Allyn, Inc.
Decision Date2013-07-03
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CP150 ELECTROCARDIOGRAPH 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 2013-07-03 under 510(k) number K131573. 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 CP150 ELECTROCARDIOGRAPH?

CP150 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K131573.

When did CP150 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

CP150 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2013-07-03, under 510(k) number K131573.

Who is the listed applicant for CP150 ELECTROCARDIOGRAPH?

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 CP150 ELECTROCARDIOGRAPH?

The FDA product code for CP150 ELECTROCARDIOGRAPH 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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