Identity
- Trade Name
- External Pacemaker Analyzer FDA UDI
- Generic Name
- External pacemaker analyser FDA UDI
- Device Name
- The EXPMT 2000 pacemaker analyzer is an advanced microprocessor based test instrument designed to accurately measure the output parameters of all external pacemakers, including both transthoracic and transcutaneous devices. The instrument is easy to use via the menu structure presented on a large four line LCD display. Resulting measurements of the tests performed are simultaneously shown on the LCD display. The EXPMT 2000 is compact, lightweight, and rugged. It may be operated with one 9 volt battery or with an optional AC adapter. A standard RS232 serial port allows for printing and storage of results with optional printers and PDAs. FDA UDI
- Model / Reference
- EXPMT 2000 FDA UDI
- Description
- The EXPMT 2000 pacemaker analyzer is an advanced microprocessor based test instrument designed to accurately measure the output parameters of all external pacemakers, including both transthoracic and transcutaneous devices. The instrument is easy to use via the menu structure presented on a large four line LCD display. Resulting measurements of the tests performed are simultaneously shown on the LCD display. The EXPMT 2000 is compact, lightweight, and rugged. It may be operated with one 9 volt battery or with an optional AC adapter. A standard RS232 serial port allows for printing and storage of results with optional printers and PDAs. FDA UDI
Identifiers
- Catalog Number
- 960 FDA UDI
- Primary DI / UDI-DI
- B3359600 FDA UDI
- 510(k) Number
- K961582 FDA UDI
- FDA Product Code
- DTC FDA UDI
- GMDN Term
- External pacemaker analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3630 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External pacemaker analyser
External Pacemaker Analyzer by Netech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- External Pacemaker Analyzer — Netech Corp. · Class II
- External Pacemaker Ananlyzer — Netech Corp. · Class II
Cleared under the same submission
K961582 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
- Netech Corp.
Sources (1)
- FDA UDI 88131229-8ae0-42b5-8179-eb20e3daf2d9 35 fields · synced Jun 8, 2026