Company ยท US
Galix Biomedical Instrumentation, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2010. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2010 | K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM Galix Biomedical Instrumentation, Inc. | MLO |
| Jan 31, 2006 | K051163 | GALIX ECG PROFESSIONAL STATION Galix Biomedical Instrumentation, Inc. | DPS |
| Sep 17, 2003 | K030145 | GALIX WINTER Galix Biomedical Instrumentation, Inc. | DQK |
| Jun 11, 2003 | K023080 | GALIX PACESTAR Galix Biomedical Instrumentation, Inc. | DTE |
| Mar 15, 2001 | K992706 | GALIX GBI -3S-LP Galix Biomedical Instrumentation, Inc. | MLO |
| Jan 29, 1998 | K971670 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER Galix Biomedical Instrumentation, Inc. | DSH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||