510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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|---|---|---|---|
| full automatic (nibp) blood pressure monitor model# hl888 | HEALTH & LIFE CO., LTD. | k042265 |
08/31/2004 |
| mucotrol concentrated oral gel wafer | BELCHER PHARMACEUTICALS, INC. | k042400 |
11/24/2004 |
| vari-able apb (adaptable positioning base) | AMERICAN TRACK ROADSTERS, INC. | k042401 |
10/07/2004 |
| modification to vertex reconstruction system | MEDTRONIC SOFAMOR DANEK, INC. | k042402 |
10/01/2004 |
| mirage swift | RESMED LTD. | k042403 |
10/08/2004 |
| lifepak, model 1000 | MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. | k042404 |
12/22/2005 |
| painpump1; painpump2 | STRYKER CORP. | k042405 |
10/14/2004 |
| olympus lactate, osr6193 | OLYMPUS AMERICA, INC. | k042406 |
12/03/2004 |
| emit caffeine assay | DADE BEHRING, INC. | k042407 |
10/28/2004 |
| iqqa-chest software package | EDDA TECHNOLOGY, INC. | k042408 |
10/08/2004 |
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