Identity
- Trade Name
- MLCL Upgrade FDA UDI
- Generic Name
- Cardiac electrophysiology analysis system FDA UDI
- Device Name
- Upgrade Kit MLCL V9.0 FDA UDI
- Model / Reference
- AltiX AI.i FDA UDI
- Description
- Upgrade Kit MLCL V9.0 FDA UDI
Identifiers
- Catalog Number
- 5973644 FDA UDI
- Primary DI / UDI-DI
- 00195278940193 FDA UDI
- 510(k) Number
- K243540 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac electrophysiology analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac catheterization monitoring systemCardiac electrophysiology analysis system
MLCL Upgrade by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac electrophysiology analysis system.
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- Pure EP - 5 x 10 pin Yoked Jumper Cable White — Biosig Technologies · Class II
- Pure EP - Catheter Input Module — Biosig Technologies · Class II
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Cleared under the same submission
K243540 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
- Ge Medical Systems Information Technologies, Inc.
Sources (1)
- FDA UDI c2a99c4c-0518-498d-b154-dcff5e137467 35 fields · synced Jun 8, 2026