FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
K Number: K002444
·
Decision Oct 18, 2000
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
13
Review Days
70
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Basic Information
- Device Name
- PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
- K Number
- K002444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sun Nuclear Corp.
- Date Received
- August 9, 2000
- Decision Date
- October 18, 2000
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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| K051921 | THE EDGE DETECTOR, MODEL 1118 | Jul 27, 2005 | Substantially Equivalent |
| K013689 | RE-ENTRANT CHAMBER | Jul 2, 2002 | Substantially Equivalent |
| K021463 | MODEL 1133 IVD PC VERSION | Jun 6, 2002 | Substantially Equivalent |
| K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | Jul 26, 2001 | Substantially Equivalent |
| K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | Jun 6, 2001 | Substantially Equivalent |
| K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 | May 4, 2001 | Substantially Equivalent |