510(k) K010164
K010164 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "ICG MODULE". The FDA issued a decision of Substantially Equivalent on April 9, 2001. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2001
- Date Received
- January 18, 2001
- 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