K033807 is an FDA 510(k) clearance for the INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER. This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).
Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on March 9, 2004, 92 days after receiving the submission on December 8, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.
| 510(k) Number | K033807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2003 |
| Decision Date | March 09, 2004 |
| Days to Decision | 92 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRQ — Amplifier And Signal Conditioner, Transducer Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2060 |