FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAVERNOSOMETRY MODULE FOR MENUET
K Number: K923117
·
Decision Feb 22, 1993
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
25
Review Days
241
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Basic Information
- Device Name
- CAVERNOSOMETRY MODULE FOR MENUET
- K Number
- K923117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dantec Medical, Inc.
- Date Received
- June 26, 1992
- Decision Date
- February 22, 1993
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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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 |
| 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 |