FDA 510(k)
Substantially Equivalent
🇺🇸 United States
AUTO D OPTION
K Number: K837430
·
Decision May 18, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
32
Review Days
19
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Basic Information
- Device Name
- AUTO D OPTION
- K Number
- K837430
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Technicare Corp.
- Date Received
- April 29, 1983
- Decision Date
- May 18, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Technicare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854340 | TECHNICARE 720 HPS CT SCANNER | Nov 15, 1985 | Substantially Equivalent |
| K852089 | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM | Jul 18, 1985 | Substantially Equivalent |
| K844293 | AUTO DII MULTI FREQUENCY | Feb 13, 1985 | Substantially Equivalent |
| K844247 | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS | Jan 23, 1985 | Substantially Equivalent |
| K843716 | NUCLEAR 700 MEDICINE MECHANICAL POSIT- | Dec 17, 1984 | Substantially Equivalent |
| K842777 | AUTOFOCUS DUAL ELEMENT PROBE | Nov 29, 1984 | Substantially Equivalent |
| K841817 | TECHNICARE 248 SL & 260SL | Aug 17, 1984 | Substantially Equivalent |
| K840860 | CENTAURI CT SCANNER | May 22, 1984 | Substantially Equivalent |
| K840540 | TECHNICARE MODEL 330 | May 9, 1984 | Substantially Equivalent |
| K834486 | TECHNICARE 280 | Apr 13, 1984 | Substantially Equivalent |