Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name: Welch Allyn, Inc. FDA UDI
Generic Name: Electrocardiograph, professional, multichannel FDA UDI
Device Name: Welch Allyn CP 150 12-Lead Resting Electrocardiograph; Noninterpretive, AHA ECG Cable with Disposable Electrodes, CardioPerfect Workstation Connectivity via USB and Ethernet, Color Touchscreen Display, 100-Test Memory; 100–240 V, 50/60 Hz AC, IEC Plug Type-B; French Language FDA UDI
Model / Reference: 901049 FDA UDI
Description: Welch Allyn CP 150 12-Lead Resting Electrocardiograph; Noninterpretive, AHA ECG Cable with Disposable Electrodes, CardioPerfect Workstation Connectivity via USB and Ethernet, Color Touchscreen Display, 100-Test Memory; 100–240 V, 50/60 Hz AC, IEC Plug Type-B; French Language FDA UDI

Identifiers

Catalog Number: CP150-1FRB FDA UDI
Primary DI / UDI-DI: 00732094192254 FDA UDI
510(k) Number: K141582 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Electrocardiograph, professional, multichannel

Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K141582 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Welch Allyn, Inc.

Sources (1)

FDA UDI f3371565-f7d4-4453-ab72-dd506c9b08f2 36 fields · synced May 31, 2026