FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BROWNE MODEL UD-4D
K Number: K792091
·
Decision Dec 6, 1979
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
7
Review Days
50
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Basic Information
- Device Name
- BROWNE MODEL UD-4D
- K Number
- K792091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Browne Corp.
- Date Received
- October 17, 1979
- Decision Date
- December 6, 1979
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAP), ordered by most recent decision date.
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
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FDA Class 2
·Gastroenterology, Urology
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
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FDA Class 2
·Gastroenterology, Urology
URODYNAMIC ANALYSIS MODULE
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FDA Class 2
·Gastroenterology, Urology
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
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FDA Class 2
·Gastroenterology, Urology
SCHUSTER DISPOSABLE BALLOON PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UROLAB SPECTRUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Browne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K792093 | BROWNE MODEL GD-5 | Dec 6, 1979 | Substantially Equivalent |
| K792092 | BROWNE MODEL UD-4E | Dec 6, 1979 | Substantially Equivalent |
| K792094 | BROWNE MODEL UA-6 | Dec 6, 1979 | Substantially Equivalent |
| K792090 | BROWNE MODEL UD-4 | Dec 6, 1979 | Substantially Equivalent |
| K790754 | BROWNE MODEL CF-1 AND CF-1G | Jun 1, 1979 | Substantially Equivalent |
| K790478 | BROWNE MODEL UD-4DE | Jun 1, 1979 | Substantially Equivalent |