510(k) K030145
K030145 is an FDA 510(k) premarket notification submitted by Galix Biomedical Instrumentation, Inc. for the device "GALIX WINTER". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Galix Biomedical Instrumentation, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2003
- Date Received
- January 15, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type