Galix Winter
FDA 510(k) K030145 · Galix Biomedical Instrumentation, Inc.
510(k) numberK030145
Submission
- Device name
- Galix Winter
- Applicant
- Galix Biomedical Instrumentation, Inc.
Miami Beach, FL, US - Received
- January 15, 2003
- Decision date
- September 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Galix Winter cleared by the FDA?
Galix Winter (K030145) received a 510(k) decision of Substantially Equivalent on September 17, 2003, 245 days after the submission was received.
What is the product code of K030145?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.