FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNAMIC CARDIAC PHANTOM 74-347
K Number: K853756
·
Decision Oct 29, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
40
Review Days
50
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Basic Information
- Device Name
- DYNAMIC CARDIAC PHANTOM 74-347
- K Number
- K853756
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Victoreen, Inc.
- Date Received
- September 9, 1985
- Decision Date
- October 29, 1985
- Product Code
- IXY
- 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 |
|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | FDA class 1 | Radiology |
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RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER
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|---|---|---|---|
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| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Jun 16, 1995 | Substantially Equivalent |
| K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM | Dec 9, 1994 | Substantially Equivalent |
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| K941931 | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR | May 26, 1994 | Substantially Equivalent |