FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDEO ENHANCEMENT UNIT
K Number: K954222
·
Decision Dec 8, 1995
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
88
Basic Information
- Device Name
- VIDEO ENHANCEMENT UNIT
- K Number
- K954222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PERKINS MFG. CO.
- Date Received
- September 11, 1995
- Decision Date
- December 8, 1995
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by PERKINS MFG. CO.
| K Number | Device Name | ||
|---|---|---|---|
| K972136 | TV MONITOR (P12/17) | Jun 26, 1997 | Substantially Equivalent |
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| K920550 | DISPLAY PROCESSOR - MODEL IDP5100 | Apr 13, 1992 | Substantially Equivalent |
| K915232 | GRUNDIG ELECTRONICS VARIOUS MODELS | Jan 9, 1992 | Substantially Equivalent |
| K910384 | VIDEO ANNOTATOR MODEL PK2310 | Apr 16, 1991 | Substantially Equivalent |
| K904986 | PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 | Dec 4, 1990 | Substantially Equivalent |
| K904540 | VIDEO SYSTEM INTERFACE MODELS | Oct 26, 1990 | Substantially Equivalent |
| K896615 | CINE CAMERA CONTROL MODEL PK2037 | Jan 4, 1990 | Substantially Equivalent |
| K895500 | PATIENT POSITIONING ACCESSORIES | Nov 6, 1989 | Substantially Equivalent |
| K893644 | PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER | Aug 9, 1989 | Substantially Equivalent |