FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOOT WEIGHT ALARM
K Number: K962591
·
Decision Dec 4, 1996
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
8
Review Days
155
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Basic Information
- Device Name
- FOOT WEIGHT ALARM
- K Number
- K962591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5575
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cleveland Medical Devices, Inc.
- Date Received
- July 2, 1996
- Decision Date
- December 4, 1996
- Product Code
- IRN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IRN | Device, Warning, Overload, External Limb, Powered | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K013863 | CRYSTAL MONITOR MODEL 16 | Feb 19, 2002 | Substantially Equivalent |
| K001110 | CRYSTAL-EEG MODEL 15 | Jul 5, 2000 | Substantially Equivalent |
| K970672 | CRYSTAL-EEG MODEL 10 (MODEL 10) | May 22, 1997 | Substantially Equivalent |
| K964690 | LIBERTY VALVE | Mar 21, 1997 | Substantially Equivalent |
| K954670 | PRESSORE MONITOR | Oct 30, 1995 | Substantially Equivalent |