Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International 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 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No co FDA UDI
- Model / Reference
- 901144 FDA UDI
- Description
- Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International 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 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No co FDA UDI
Identifiers
- Catalog Number
- QS-6AC-DFAAX FDA UDI
- Primary DI / UDI-DI
- 00732094263763 FDA UDI
- 510(k) Number
- K152944 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic lead set, reusable
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K152944 also covers:
- AM12Q — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
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 9cf971da-a57c-4406-8739-693fd1c6b5df 36 fields · synced Jun 8, 2026