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: Q-Stress Cardiac Stress- ver 6 with adult and ped interp; includes current software CD, user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Swf kit; UK power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 25" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface FDA UDI
Model / Reference: 901007 FDA UDI
Description: Q-Stress Cardiac Stress- ver 6 with adult and ped interp; includes current software CD, user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Swf kit; UK power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 25" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface FDA UDI

Identifiers

Catalog Number: QS-6AC-CFBAB FDA UDI
Primary DI / UDI-DI: 00732094318029 FDA UDI
510(k) Number: K093339 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

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

K093339 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 c927720a-bf13-4892-8bb0-684070f85ca8 36 fields · synced May 30, 2026