FDA 510(k) Applications Submitted by TOM SHANKS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120920 |
03/27/2012 |
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA |
HSINER COMPANY |
| K070948 |
04/04/2007 |
HSINER NEBULIZER BOTTLE |
HSINER |
| K091185 |
04/23/2009 |
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER |
HSINER CO., LTD. |
| K051279 |
05/17/2005 |
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 |
CALDYNE, INC. |
| K021742 |
05/28/2002 |
GALEMED NEB-EASY NEBULIZER |
GALEMED CORP. |
| K082009 |
07/23/2008 |
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS |
HSINER CO., LTD. |
| K102120 |
07/29/2010 |
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 |
HSINER CO., LTD. |
| K122627 |
08/28/2012 |
GIO DIGITAL PRESSURE GUAGES |
GALEMED CORP. |
| K132679 |
08/28/2013 |
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER |
GALEMED CORP. |
| K102719 |
09/21/2010 |
ATLANTEAN TRIGGER NEBULIZER |
ATLANTEAN CORPORATION |
| K052811 |
10/04/2005 |
HSINER JET NEBULIZER, MODEL HS-31100 |
HSINER CO., LTD. |
| K063268 |
10/30/2006 |
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 |
HSINER CO., LTD. |
| K053466 |
12/13/2005 |
HSINER RESUSCITATOR |
HSINER CO., LTD. |
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