FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QardioCore
K Number: K201644
·
Decision Feb 28, 2021
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
3
Review Days
256
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Basic Information
- Device Name
- QardioCore
- K Number
- K201644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qardio, Inc.
- Date Received
- June 17, 2020
- Decision Date
- February 28, 2021
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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