FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇸🇪 Sweden
ROBO
K Number: K942508
·
Decision Nov 7, 1994
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
15
Review Days
165
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Basic Information
- Device Name
- ROBO
- K Number
- K942508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Permobil AB
- Date Received
- May 26, 1994
- Decision Date
- November 7, 1994
- 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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| K041219 | ELECTRO | Aug 4, 2004 | Substantially Equivalent |
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