The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinityedical Information Bus (mib/mib Ii And Mib Duo) Protocol Converter.
| Device ID | K033807 |
| 510k Number | K033807 |
| Device Name: | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Greco |
| Correspondent | Penelope H Greco Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | DRQ |
| Subsequent Product Code | BSZ |
| Subsequent Product Code | CBK |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-08 |
| Decision Date | 2004-03-09 |
| Summary: | summary |