FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
K Number: K920992
·
Decision Apr 10, 1992
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
7
Review Days
56
Basic Information
- Device Name
- PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
- K Number
- K920992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BROWNE MEDICAL SYSTEMS, INC.
- Date Received
- February 14, 1992
- Decision Date
- April 10, 1992
- 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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Other Clearances by BROWNE MEDICAL SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Apr 10, 1992 | Substantially Equivalent |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Apr 10, 1992 | Substantially Equivalent |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | Jun 10, 1991 | Substantially Equivalent |
| K910371 | URODYNAMIC MEASURING SYSTEM | May 15, 1991 | Substantially Equivalent |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | Apr 2, 1991 | Substantially Equivalent |
| K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP | Apr 2, 1991 | Substantially Equivalent |