510(k) K112830
K112830 is an FDA 510(k) premarket notification submitted by Noninvasive Medical Technologies, Inc. for the device "ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)". The FDA issued a decision of Substantially Equivalent on November 13, 2012. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Noninvasive Medical Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2012
- Date Received
- September 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type