510(k) K050974
K050974 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS". The FDA issued a decision of Substantially Equivalent on Apr 29, 2005. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Draeger Medical Systems, Inc. has 48 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 2005
- Date Received
- Apr 18, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Transducer Signal
- Device Class
- Class II
- Regulation Number
- 870.2060
- Review Panel
- CV
- Submission Type
- 510(k)