510(k) K110645
K110645 is an FDA 510(k) premarket notification submitted by Sonosite,Inc. for the device "BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR". The FDA issued a decision of Substantially Equivalent on June 3, 2011. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Sonosite,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2011
- Date Received
- March 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type