FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
S HEALTH
K Number: K132148
·
Decision Dec 4, 2013
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
40
Review Days
146
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Basic Information
- Device Name
- S HEALTH
- K Number
- K132148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Samsung Electronics Co., Ltd.
- Date Received
- July 11, 2013
- Decision Date
- December 4, 2013
- 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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