FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-DOP X
K Number: K931801
·
Decision Jun 14, 1995
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
25
Review Days
867
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Basic Information
- Device Name
- MULTI-DOP X
- K Number
- K931801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dantec Medical, Inc.
- Date Received
- January 28, 1993
- Decision Date
- June 14, 1995
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Dantec Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960503 | DANTEC DUET | Sep 16, 1996 | Substantially Equivalent |
| K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | Mar 25, 1996 | Substantially Equivalent |
| K953999 | DANTEC DA CAPO | Nov 21, 1995 | Substantially Equivalent |
| K926363 | MULTI-DOP S | Jun 19, 1995 | Substantially Equivalent |
| K930458 | MULTI-DOP L | Feb 3, 1995 | Substantially Equivalent |
| K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE | Oct 4, 1994 | Substantially Equivalent |
| K934580 | DANTEC 13R45 BAR ELECTRODE | Sep 26, 1994 | Substantially Equivalent |
| K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE | Mar 30, 1994 | Substantially Equivalent |
| K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | Nov 9, 1993 | Substantially Equivalent |
| K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | Aug 31, 1993 | Substantially Equivalent |