510(k) K010640

SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER by Siemens Medical Solutions USA, Inc. — Product Code DRQ

K010640 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER". The FDA issued a decision of Substantially Equivalent on March 20, 2001. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2001
Date Received
March 5, 2001
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