FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICARE MODEL 1047
K Number: K840390
·
Decision Feb 21, 1984
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
32
Review Days
22
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Basic Information
- Device Name
- TECHNICARE MODEL 1047
- K Number
- K840390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Technicare Corp.
- Date Received
- January 30, 1984
- Decision Date
- February 21, 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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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 |