FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440
K Number: K837033
·
Decision Mar 9, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
85
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Basic Information
- Device Name
- ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440
- K Number
- K837033
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Radiation Measurements, Inc.
- Date Received
- December 14, 1982
- Decision Date
- March 9, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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| K834483 | DIGI-X | Mar 5, 1984 | Substantially Equivalent |
| K834607 | ELECTRONIC KVP CASSETTE | Feb 21, 1984 | Substantially Equivalent |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Jan 25, 1984 | Substantially Equivalent |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Jan 25, 1984 | Substantially Equivalent |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Dec 2, 1981 | Substantially Equivalent |