FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URODYNAMIC INSTRUMENTS
K Number: K770897
·
Decision Jun 3, 1977
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
15
Applicant Total
19
Review Days
18
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Basic Information
- Device Name
- URODYNAMIC INSTRUMENTS
- K Number
- K770897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Instruments, Inc.
- Date Received
- May 16, 1977
- Decision Date
- June 3, 1977
- Product Code
- EXY
- 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 |
|---|---|---|---|
| EXY | Uroflowmeter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY
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Other Clearances by Life-Tech Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Sep 9, 1981 | Substantially Equivalent |
| K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER | Aug 25, 1981 | Substantially Equivalent |
| K812180 | LIFE-TECH #5102 VISULAB | Aug 21, 1981 | Substantially Equivalent |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | Aug 13, 1981 | Substantially Equivalent |
| K800112 | AMBLYOPIA TRAINER | Mar 10, 1980 | Substantially Equivalent |
| K790663 | MODEL 1750 STANDING URINAL | Apr 24, 1979 | Substantially Equivalent |
| K790664 | MODEL 1309 AUDIO MONITOR | Apr 23, 1979 | Substantially Equivalent |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Nov 15, 1978 | Substantially Equivalent |
| K781461 | MODEL 7320 VISUAL STIMULATOR | Nov 8, 1978 | Substantially Equivalent |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Sep 7, 1978 | Substantially Equivalent |