FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
STOMAVISION (STV)
K Number: K913464
·
Decision Nov 13, 1991
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
16
Review Days
100
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Basic Information
- Device Name
- STOMAVISION (STV)
- K Number
- K913464
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trophy Radiologie
- Date Received
- August 5, 1991
- Decision Date
- November 13, 1991
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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|---|---|---|---|
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| K023346 | TROPHYPAN | Jan 3, 2003 | Substantially Equivalent |
| K012514 | DIGIPAN / DPI | Dec 21, 2001 | Substantially Equivalent |
| K991455 | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, | Jun 25, 1999 | Substantially Equivalent |
| K991912 | MODIFICATION TO DIGIPAN | Jun 22, 1999 | Substantially Equivalent |
| K961826 | DIGIPAN | Sep 23, 1996 | Substantially Equivalent |
| K962337 | ELITYS OR ELITYS-E | Jul 25, 1996 | Substantially Equivalent |
| K953936 | ATLANTIS | Dec 28, 1995 | Substantially Equivalent |
| K951074 | STOMAVISION (STV) | Sep 19, 1995 | Substantially Equivalent |