510(k) K023080
K023080 is an FDA 510(k) premarket notification submitted by Galix Biomedical Instrumentation, Inc. for the device "GALIX PACESTAR". The FDA issued a decision of Substantially Equivalent on June 11, 2003. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Galix Biomedical Instrumentation, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2003
- Date Received
- September 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pulse-Generator, Pacemaker, External
- Device Class
- Class II
- Regulation Number
- 870.3600
- Review Panel
- CV
- Submission Type