Identity
- Trade Name
- Hokanson FDA UDI
- Generic Name
- Electrocardiographic modulated activator FDA UDI
- Device Name
- ECG TRIGGER - A battery powered instrument used to acquire an ECG signal from a subject. The instrument filters and amplifies the patient's ECG R-wave, then sends the signal to a parent device via and optically isolated interface cable. The output signal can be used by the parent device to synchronize another event with the subject’s R-Wave. The waveform is NOT used for analysis or diagnosis due to the ECG signal filtering. FDA UDI
- Model / Reference
- RT2000 FDA UDI
- Description
- ECG TRIGGER - A battery powered instrument used to acquire an ECG signal from a subject. The instrument filters and amplifies the patient's ECG R-wave, then sends the signal to a parent device via and optically isolated interface cable. The output signal can be used by the parent device to synchronize another event with the subject’s R-Wave. The waveform is NOT used for analysis or diagnosis due to the ECG signal filtering. FDA UDI
Identifiers
- Catalog Number
- 00334 FDA UDI
- Primary DI / UDI-DI
- 00817065021396 FDA UDI
- 510(k) Number
- K023707 FDA UDI
- FDA Product Code
- JOM FDA UDI
- GMDN Term
- Electrocardiographic modulated activator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2780 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: Electrocardiographic modulated activator
Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic modulated activator.
- Iradimed — Iradimed Corporation · Class II
Cleared under the same submission
K023707 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
- D. E. Hokanson, Inc.
Sources (1)
- FDA UDI b5f0b38a-0bb6-4ec1-a521-6cc0ece3e97f 36 fields · synced Jun 8, 2026