FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SATURNE I LINEAR ACCELERATOR
K Number: K837412
·
Decision Jun 28, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
20
Review Days
68
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Basic Information
- Device Name
- SATURNE I LINEAR ACCELERATOR
- K Number
- K837412
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cgr Medical Corp.
- Date Received
- April 21, 1983
- Decision Date
- June 28, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Cgr Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843926 | PRESTILIX 1690 | Dec 17, 1984 | Substantially Equivalent |
| K843235 | STENOSCOP | Nov 8, 1984 | Substantially Equivalent |
| K843985 | SUSPENSION 7 | Nov 5, 1984 | Substantially Equivalent |
| K841649 | MAXIMAX - 4 | Jun 5, 1984 | Substantially Equivalent |
| K833223 | SONEL 3000A | May 9, 1984 | Substantially Equivalent |
| K834306 | PHASIX-HIGH FREQUENCY GENERATOR | Dec 29, 1983 | Substantially Equivalent |
| K833941 | ORION | Dec 29, 1983 | Substantially Equivalent |
| K833846 | PROCESS 100 ST | Dec 16, 1983 | Substantially Equivalent |
| K837465 | ALCYON ROTATIONAL COBALT THERAPY | Jun 28, 1983 | Substantially Equivalent |
| K837336 | VERASUN RADIATION THERAPY SIMULATION SYSTEM | Apr 29, 1983 | Substantially Equivalent |