510(k) K041434
K041434 is an FDA 510(k) premarket notification submitted by Analogic Corp. for the device "C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS". The FDA issued a decision of Substantially Equivalent on Aug 6, 2004. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Analogic Corp. has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 2004
- Date Received
- May 28, 2004
- 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
- 510(k)