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: PCE-210 PC-Based Exercise Stress System (treadmill, no computer); 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill, stress belt, stress electrodes and manuals on CD) FDA UDI
Model / Reference: 901047 FDA UDI
Description: PCE-210 PC-Based Exercise Stress System (treadmill, no computer); 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill, stress belt, stress electrodes and manuals on CD) FDA UDI

Identifiers

Catalog Number: CPSP-UN-UC-D-T FDA UDI
Primary DI / UDI-DI: 00732094088595 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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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

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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

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 c70b2ff0-95ab-4aeb-adc0-df9f9aa68da7 37 fields · synced Jun 1, 2026