FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LE-12CH
K Number: K220362
·
Decision Mar 25, 2022
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
3
Review Days
45
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Basic Information
- Device Name
- LE-12CH
- K Number
- K220362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caf Medical Solutions, Inc.
- Date Received
- February 8, 2022
- Decision Date
- March 25, 2022
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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