FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URDYN 5000 (UROFLOWMETER)
K Number: K860368
·
Decision Apr 23, 1986
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
4
Applicant Total
12
Review Days
79
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Basic Information
- Device Name
- URDYN 5000 (UROFLOWMETER)
- K Number
- K860368
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dantec Electronics, Inc.
- Date Received
- February 3, 1986
- Decision Date
- April 23, 1986
- Product Code
- FFO
- 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 |
|---|---|---|---|
| FFO | Retractor, Self-Retaining | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Dantec Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | Jun 18, 1990 | Substantially Equivalent |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | May 14, 1990 | Substantially Equivalent |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | Oct 4, 1989 | Substantially Equivalent |
| K881915 | DANTEC MAGNETIC STIMULATOR | Oct 17, 1988 | Substantially Equivalent |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | Apr 14, 1988 | Substantially Equivalent |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | Apr 14, 1988 | Substantially Equivalent |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | Jan 22, 1988 | Substantially Equivalent |
| K870567 | EVOPORT 300 | Oct 6, 1987 | Substantially Equivalent |
| K872106 | DANTEC COUNTERPOINT | Sep 10, 1987 | Substantially Equivalent |
| K853119 | URODYN 1000 | Oct 4, 1985 | Substantially Equivalent |