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PC Electrometer Reference Class Dual-Channel Electrometer (BNC)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- PC Electrometer Reference Class Dual-Channel Electrometer (BNC) FDA UDI
- Generic Name
- Radiation electrometer FDA UDI
- Device Name
- Radiation therapy QA device. FDA UDI
- Model / Reference
- 1014300Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 1014000-0Z FDA UDI
- Primary DI / UDI-DI
- 05060608880065 FDA UDI
- 510(k) Number
- K092019 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation electrometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation electrometer
PC Electrometer Reference Class Dual-Channel Electrometer (BNC) by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K092019 also covers:
Manufacturer's product page: PC Electrometer Portable, Reference-Class Electrometer
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
- Sun Nuclear Corporation
Sources (1)
- FDA UDI d996ca38-82eb-4e42-9233-03ee9669aec9 36 fields · synced Jun 8, 2026