FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANNE Chest
K Number: K240251
·
Decision Jun 3, 2024
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
5
Review Days
125
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Basic Information
- Device Name
- ANNE Chest
- K Number
- K240251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sibel Health, Inc.
- Date Received
- January 30, 2024
- Decision Date
- June 3, 2024
- Product Code
- DRG
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
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