FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANTEC DA CAPO
K Number: K953999
·
Decision Nov 21, 1995
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
15
Applicant Total
25
Review Days
89
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Basic Information
- Device Name
- DANTEC DA CAPO
- K Number
- K953999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dantec Medical, Inc.
- Date Received
- August 24, 1995
- Decision Date
- November 21, 1995
- Product Code
- EXY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EXY | Uroflowmeter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXY), ordered by most recent decision date.
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UROPOWER
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GR100F URINE FLOWMETER
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FLOLAB
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URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY
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4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K926363 | MULTI-DOP S | Jun 19, 1995 | Substantially Equivalent |
| K931801 | MULTI-DOP X | Jun 14, 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 |