FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEVAMATIC 3
K Number: K854609
·
Decision Feb 21, 1986
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
13
Review Days
95
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Basic Information
- Device Name
- MEVAMATIC 3
- K Number
- K854609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Medical Laboratories, Inc.
- Date Received
- November 18, 1985
- Decision Date
- February 21, 1986
- Product Code
- JAD
- 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 |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | FDA class 2 | Radiology |
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Other Clearances by Siemens Medical Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910971 | Z XT RADIATION THERAPY TREATMENT TABLE | May 3, 1991 | Substantially Equivalent |
| K903139 | BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) | Nov 7, 1990 | Substantially Equivalent |
| K894230 | PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) | Aug 28, 1989 | Substantially Equivalent |
| K882729 | MEVATRON, M 2 CLASS | Sep 19, 1988 | Substantially Equivalent |
| K875272 | SONOLINE CF | Feb 18, 1988 | Substantially Equivalent |
| K862339 | MEVATRON KD-2 | Oct 29, 1986 | Substantially Equivalent |
| K852907 | SIEMENS MEVATRON ME | Sep 19, 1985 | Substantially Equivalent |
| K812032 | MEVATRON 67E | Aug 18, 1981 | Substantially Equivalent |
| K791967 | MEVATRON 74X MEDICAL LINEAR ACCELERATOR | Nov 16, 1979 | Substantially Equivalent |
| K790747 | MEVATRON 74 | May 4, 1979 | Substantially Equivalent |