FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1 VIDEO TAPE RECORDER MODEL BK-224 H
K Number: K892934
·
Decision Jul 20, 1989
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
81
Applicant Total
14
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 1 VIDEO TAPE RECORDER MODEL BK-224 H
- K Number
- K892934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Perkins Mfg. Co.
- Date Received
- April 21, 1989
- Decision Date
- July 20, 1989
- Product Code
- OXO
- 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 |
|---|---|---|---|
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXO), ordered by most recent decision date.
Digital C-ARM with 3D
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan TAU MVP Mini C-Arm System
FDA 510(k)
FDA Class 2
·Radiology
OEC One CFD
FDA 510(k)
FDA Class 2
·Radiology
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan TAU Mini C-Arm
FDA 510(k)
FDA Class 2
·Radiology
Orthoscan VERSA Mini C-Arm
FDA 510(k)
FDA Class 2
·Radiology
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 |