FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUSION
K Number: K061912
·
Decision Aug 1, 2006
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
7
Review Days
26
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Basic Information
- Device Name
- FUSION
- K Number
- K061912
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Burke, Inc.
- Date Received
- July 6, 2006
- Decision Date
- August 1, 2006
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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Other Clearances by Burke, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023961 | SCOUT BOSS | Dec 24, 2002 | Substantially Equivalent |
| K982158 | SCOUT | Aug 31, 1998 | Substantially Equivalent |
| K965123 | PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) | Jul 17, 1997 | Substantially Equivalent |
| K911943 | CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM | Jul 19, 1991 | Substantially Equivalent |
| K893706 | COLD/HOT FLUID RADIATION PAD NEUTECH | Jun 22, 1989 | Substantially Equivalent |
| K834506 | PACESAVER & SCOUT | Jan 30, 1984 | Substantially Equivalent |