510(k) K151040
K151040 is an FDA 510(k) premarket notification submitted by Biometrix , Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on September 4, 2015. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Biometrix , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2015
- Date Received
- April 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type