FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER
K Number: K893644
·
Decision Aug 9, 1989
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
14
Review Days
86
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Basic Information
- Device Name
- PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER
- K Number
- K893644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Perkins Mfg. Co.
- Date Received
- May 15, 1989
- Decision Date
- August 9, 1989
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 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 |
| K954222 | VIDEO ENHANCEMENT UNIT | Dec 8, 1995 | Substantially Equivalent |
| K926348 | SC1000 SCAN CONVERTER | Nov 19, 1993 | Substantially Equivalent |
| 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 |