FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
URODYNAMIC ANALYSIS MODULE
K Number: K963330
·
Decision Apr 3, 1997
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
5
Review Days
223
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Basic Information
- Device Name
- URODYNAMIC ANALYSIS MODULE
- K Number
- K963330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synectics Medical, Inc.
- Date Received
- August 23, 1996
- Decision Date
- April 3, 1997
- Product Code
- FAP
- 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 |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | FDA class 2 | Gastroenterology, Urology |
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