510(k) K014063
K014063 is an FDA 510(k) premarket notification submitted by Cnsystems Medizintechnik GmbH for the device "TASK FORCE MONITOR 3040". The FDA issued a decision of Substantially Equivalent on Feb 7, 2002. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Cnsystems Medizintechnik GmbH has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 7, 2002
- Date Received
- Dec 11, 2001
- 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
- 510(k)