FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALIX PACESTAR
K Number: K023080
·
Decision Jun 11, 2003
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
6
Review Days
267
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Basic Information
- Device Name
- GALIX PACESTAR
- K Number
- K023080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Galix Biomedical Instrumentation, Inc.
- Date Received
- September 17, 2002
- Decision Date
- June 11, 2003
- Product Code
- DTE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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Other Clearances by Galix Biomedical Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Jul 9, 2010 | Substantially Equivalent |
| K051163 | GALIX ECG PROFESSIONAL STATION | Jan 31, 2006 | Substantially Equivalent |
| K030145 | GALIX WINTER | Sep 17, 2003 | Substantially Equivalent |
| K992706 | GALIX GBI -3S-LP | Mar 15, 2001 | Substantially Equivalent |
| K971670 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER | Jan 29, 1998 | Substantially Equivalent |