FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM
K Number: K940660
·
Decision Dec 9, 1994
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
40
Review Days
297
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Basic Information
- Device Name
- MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM
- K Number
- K940660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Victoreen, Inc.
- Date Received
- February 15, 1994
- Decision Date
- December 9, 1994
- 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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| K971382 | PRONE BREAST POSITIONING BOARD, MODEL #37-018 | Jun 6, 1997 | Substantially Equivalent |
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Jun 16, 1995 | Substantially Equivalent |
| K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST | Jul 29, 1994 | Substantially Equivalent |
| K941931 | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR | May 26, 1994 | Substantially Equivalent |
| K934549 | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD | Feb 19, 1994 | Substantially Equivalent |