510(k) K051163
K051163 is an FDA 510(k) premarket notification submitted by Galix Biomedical Instrumentation, Inc. for the device "GALIX ECG PROFESSIONAL STATION". The FDA issued a decision of Substantially Equivalent on January 31, 2006. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Galix Biomedical Instrumentation, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2006
- Date Received
- May 5, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type