FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fitbit ECG App
K Number: K200948
·
Decision Sep 11, 2020
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
3
Review Days
156
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Basic Information
- Device Name
- Fitbit ECG App
- K Number
- K200948
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2345
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fitbit, Inc.
- Date Received
- April 8, 2020
- Decision Date
- September 11, 2020
- Product Code
- QDA
- 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 |
|---|---|---|---|
| QDA | Electrocardiograph Software For Over-The-Counter Use | FDA class 2 | Cardiovascular |
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