FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
K Number: K021360
·
Decision Jun 10, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
8
Review Days
406
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Basic Information
- Device Name
- SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
- K Number
- K021360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Tec,Inc.
- Date Received
- April 30, 2002
- Decision Date
- June 10, 2003
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | Dec 23, 2002 | Substantially Equivalent |
| K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE | Sep 27, 2002 | Substantially Equivalent |
| K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX | Aug 30, 2000 | Substantially Equivalent |
| K981992 | ELECTRON WEDGE MODEL MT-EW-1000 | Dec 15, 1998 | Substantially Equivalent |
| K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | Oct 26, 1998 | Substantially Equivalent |