K020277 is an FDA 510(k) clearance for the SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER. This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).
Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on February 19, 2002, 22 days after receiving the submission on January 28, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.
| 510(k) Number | K020277 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2002 |
| Decision Date | February 19, 2002 |
| Days to Decision | 22 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 |