FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOTILITY MEASUREMENT SYS MMS-100
K Number: K832869
·
Decision Oct 31, 1983
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
9
Review Days
68
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Basic Information
- Device Name
- MOTILITY MEASUREMENT SYS MMS-100
- K Number
- K832869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Narco Bio-Systems
- Date Received
- August 24, 1983
- Decision Date
- October 31, 1983
- Product Code
- FFX
- 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Narco Bio-Systems
| K Number | Device Name | ||
|---|---|---|---|
| K853683 | UMS-100 | Jan 10, 1986 | Substantially Equivalent |
| K833656 | NARCOTRACE 40 - NT40 | May 9, 1984 | 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 |