FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SimpleSENSE Platform
K Number: K212160
·
Decision Sep 22, 2021
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
4
Review Days
72
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Basic Information
- Device Name
- SimpleSENSE Platform
- K Number
- K212160
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanowear, Inc.
- Date Received
- July 12, 2021
- Decision Date
- September 22, 2021
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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