FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SureSigns VS3, SureSigns VS4
K Number: K151761
·
Decision Sep 29, 2015
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
5
Applicant Total
4
Review Days
92
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Basic Information
- Device Name
- SureSigns VS3, SureSigns VS4
- K Number
- K151761
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phillips Medical Systems
- Date Received
- June 29, 2015
- Decision Date
- September 29, 2015
- Product Code
- DSJ
- 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 |
|---|---|---|---|
| DSJ | Alarm, Blood-Pressure | FDA class 2 | Cardiovascular |
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