Identity
- Trade Name
- External Pacemaker Ananlyzer FDA UDI
- Generic Name
- External pacemaker analyser FDA UDI
- Device Name
- The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers. Operation of the analyzer is menu driven via eight tactile keys and a large four line LCD display. Test measurements are simultaneously presented on the display. Five ECG snaps are standard along with an RS-232 serial port that allows for printing both a heading and test measurements on a separate printer. Information may also be sent to an external device. The external test load has twelve user-selectable loads from 100 to 1000 Ohms for use with transcutaneous pacemakers. FDA UDI
- Model / Reference
- EXPMT 2000 FDA UDI
- Description
- The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers. Operation of the analyzer is menu driven via eight tactile keys and a large four line LCD display. Test measurements are simultaneously presented on the display. Five ECG snaps are standard along with an RS-232 serial port that allows for printing both a heading and test measurements on a separate printer. Information may also be sent to an external device. The external test load has twelve user-selectable loads from 100 to 1000 Ohms for use with transcutaneous pacemakers. FDA UDI
Identifiers
- Catalog Number
- 950 FDA UDI
- Primary DI / UDI-DI
- B3359500 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External pacemaker analyser
External Pacemaker Ananlyzer by Netech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External pacemaker analyser.
- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- External Pacemaker Analyzer — Netech Corp. · Class II
- External Pacemaker Analyzer — 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 7132e39e-e704-4618-bee4-99f5f522293b 35 fields · synced May 29, 2026