510(k) K042113
K042113 is an FDA 510(k) premarket notification submitted by Noninvasive Medical Technologies, LLC for the device "ZOE FLUID STATUS MONITOR". The FDA issued a decision of Substantially Equivalent on September 14, 2004. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Noninvasive Medical Technologies, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2004
- Date Received
- August 5, 2004
- Clearance Type
- Special
- 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