FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UMS-100
K Number: K853683
·
Decision Jan 10, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
84
Applicant Total
9
Review Days
128
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Basic Information
- Device Name
- UMS-100
- K Number
- K853683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Narco Bio-Systems
- Date Received
- September 4, 1985
- Decision Date
- January 10, 1986
- 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 Narco Bio-Systems
| K Number | Device Name | ||
|---|---|---|---|
| K833656 | NARCOTRACE 40 - NT40 | May 9, 1984 | Substantially Equivalent |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | Oct 31, 1983 | Substantially Equivalent |
| K813502 | NARCO TELECARE ISOFLO PRESSURE MONITOR | Dec 29, 1981 | Substantially Equivalent |
| K811376 | ULTRASONIC QFM SYSTEM 1000 | Aug 13, 1981 | Substantially Equivalent |
| K810431 | NARCO TLECARE MINIATURE PRESSURE DOME | Mar 11, 1981 | Substantially Equivalent |
| K801544 | PORTA-FIB LPD | Jul 14, 1980 | Substantially Equivalent |
| K760084 | MONITOR, GSR (NB-401) | Jul 26, 1976 | Substantially Equivalent |
| K760083 | PHYSIOSCOPE | Jul 20, 1976 | Substantially Equivalent |