FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRON WEDGE MODEL MT-EW-1000
K Number: K981992
·
Decision Dec 15, 1998
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
8
Review Days
190
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Basic Information
- Device Name
- ELECTRON WEDGE MODEL MT-EW-1000
- K Number
- K981992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Tec,Inc.
- Date Received
- June 8, 1998
- Decision Date
- December 15, 1998
- Product Code
- IXI
- 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 |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | FDA class 2 | Radiology |
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|---|---|---|---|
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| K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 | Jun 10, 2003 | Substantially Equivalent |
| 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 |
| K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | Oct 26, 1998 | Substantially Equivalent |