FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BI-4520 DUAL IMPEDOMETER
K Number: K821723
·
Decision Sep 15, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
98
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Basic Information
- Device Name
- BI-4520 DUAL IMPEDOMETER
- K Number
- K821723
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Farrall Instruments, Inc.
- Date Received
- June 9, 1982
- Decision Date
- September 15, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K940128 | CAT-400UL PENILE PLETHYSMOGRAPH | Jan 10, 1995 | Substantially Equivalent |
| K821664 | PP-100, PERSONAL PERINEOMETER | Jul 13, 1982 | Substantially Equivalent |
| K792305 | A SLEEP ASSESSMENT DEVICE | Dec 20, 1979 | Substantially Equivalent |
| K781634 | VISUALAX | Oct 3, 1978 | Substantially Equivalent |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | Jul 20, 1976 | Substantially Equivalent |