FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K Number: K881688
·
Decision May 18, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
11
Applicant Total
88
Review Days
29
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Basic Information
- Device Name
- DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
- K Number
- K881688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1620
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Adac Laboratories
- Date Received
- April 19, 1988
- Decision Date
- May 18, 1988
- Product Code
- IZJ
- 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 |
|---|---|---|---|
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | FDA class 2 | Radiology |
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