FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
K Number: K202979
·
Decision Dec 21, 2020
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
1
Review Days
82
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Basic Information
- Device Name
- MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
- K Number
- K202979
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lode B.V.
- Date Received
- September 30, 2020
- Decision Date
- December 21, 2020
- Product Code
- ISD
- 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
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