FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
16ch Foot/ Ankle SPEEDER
K Number: K181697
·
Decision Jul 11, 2018
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
21
Review Days
14
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Basic Information
- Device Name
- 16ch Foot/ Ankle SPEEDER
- K Number
- K181697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quality Electrodynamics, LLC
- Date Received
- June 27, 2018
- Decision Date
- July 11, 2018
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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| K162623 | 16ch T/R Hand Wrist Coil | Dec 9, 2016 | Substantially Equivalent |
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