FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLURIMAT;RADIOGRAPHIC TUBE MOUNT
K Number: K781065
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
18
Review Days
21
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Basic Information
- Device Name
- PLURIMAT;RADIOGRAPHIC TUBE MOUNT
- K Number
- K781065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Tecnomed, Inc.
- Date Received
- June 26, 1978
- Decision Date
- July 17, 1978
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Tecnomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892226 | TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE | Apr 26, 1989 | Substantially Equivalent |
| K854203 | TEC 2720 MAMEX DC MAG | Mar 6, 1986 | Substantially Equivalent |
| K827124 | RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC | Mar 5, 1982 | Substantially Equivalent |
| K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Mar 5, 1982 | Substantially Equivalent |
| K820307 | TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE | Mar 5, 1982 | Substantially Equivalent |
| K827126 | TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE | Mar 5, 1982 | Substantially Equivalent |
| K827125 | RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC | Mar 4, 1982 | Substantially Equivalent |
| K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Mar 4, 1982 | Substantially Equivalent |
| K811197 | SUPERIX 120 | Jun 9, 1981 | Substantially Equivalent |
| K811195 | ARGOSTAT | Jun 9, 1981 | Substantially Equivalent |