FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K Number: K002446
·
Decision Oct 23, 2000
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
13
Review Days
75
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Basic Information
- Device Name
- RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
- K Number
- K002446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sun Nuclear Corp.
- Date Received
- August 9, 2000
- Decision Date
- October 23, 2000
- Product Code
- KXK
- 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by Sun Nuclear Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K112981 | SUN 125C IONIZATION CHAMBER | Jan 25, 2012 | Substantially Equivalent |
| K101992 | 3D SCANNER, MODEL 1230 | Oct 1, 2010 | Substantially Equivalent |
| K092019 | MODEL 1014 PC ELECTROMETER | Sep 15, 2009 | Substantially Equivalent |
| K063021 | PROFILER 2 | Nov 22, 2006 | Substantially Equivalent |
| 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 |