FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STENOSCOP
K Number: K843235
·
Decision Nov 8, 1984
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
20
Review Days
84
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Basic Information
- Device Name
- STENOSCOP
- K Number
- K843235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cgr Medical Corp.
- Date Received
- August 16, 1984
- Decision Date
- November 8, 1984
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K833223 | SONEL 3000A | May 9, 1984 | Substantially Equivalent |
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| K833941 | ORION | Dec 29, 1983 | Substantially Equivalent |
| K833846 | PROCESS 100 ST | Dec 16, 1983 | Substantially Equivalent |
| K837412 | SATURNE I LINEAR ACCELERATOR | Jun 28, 1983 | Substantially Equivalent |
| K837465 | ALCYON ROTATIONAL COBALT THERAPY | Jun 28, 1983 | Substantially Equivalent |
| K837336 | VERASUN RADIATION THERAPY SIMULATION SYSTEM | Apr 29, 1983 | Substantially Equivalent |