510(k) K020277

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

K020277 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER". The FDA issued a decision of Substantially Equivalent on February 19, 2002. 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
February 19, 2002
Date Received
January 28, 2002
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