Identity
- Trade Name
- Hokanson FDA UDI
- Generic Name
- Limb plethysmograph FDA UDI
- Device Name
- STRAIN GAUGE AND PHOTO PLETHYSMOGRAPH; 100V - A mains powered plethysmograph instrument. The user can select between strain gauge and photo plethysmography modes. An analog meter on the front of the instrument indicates the signal level and is calibrated in % Volume Change for strain gauge applications. The plethysmograph signal is also available via analog and digital outputs, to a separate recording device. FDA UDI
- Model / Reference
- EC6 FDA UDI
- Description
- STRAIN GAUGE AND PHOTO PLETHYSMOGRAPH; 100V - A mains powered plethysmograph instrument. The user can select between strain gauge and photo plethysmography modes. An analog meter on the front of the instrument indicates the signal level and is calibrated in % Volume Change for strain gauge applications. The plethysmograph signal is also available via analog and digital outputs, to a separate recording device. FDA UDI
Identifiers
- Catalog Number
- 00537 FDA UDI
- Primary DI / UDI-DI
- 00817065021280 FDA UDI
- 510(k) Number
- K982707 FDA UDI
- FDA Product Code
- JOM FDA UDI
- GMDN Term
- Limb plethysmograph 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: Limb plethysmograph
Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K982707 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 07db6324-93dd-4fe2-bedb-68a03e328a29 36 fields · synced Jun 8, 2026