FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
K Number: K151040
·
Decision Sep 4, 2015
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
4
Review Days
137
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Basic Information
- Device Name
- Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
- K Number
- K151040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biometrix , Ltd.
- Date Received
- April 20, 2015
- Decision Date
- September 4, 2015
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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