Siemens Medical Information Bus (Mib II) Protocol Converter
FDA 510(k) K010640 · Siemens Medical Solutions USA, Inc.
510(k) numberK010640
Submission
- Device name
- Siemens Medical Information Bus (Mib II) Protocol Converter
- Applicant
- Siemens Medical Solutions USA, Inc.
Danvers, MA, US - Received
- March 5, 2001
- Decision date
- March 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRQ – Amplifier And Signal Conditioner, Transducer Signal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2060
- Specialty
- Cardiovascular
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Questions and answers
When was Siemens Medical Information Bus (Mib II) Protocol Converter cleared by the FDA?
Siemens Medical Information Bus (Mib II) Protocol Converter (K010640) received a 510(k) decision of Substantially Equivalent on March 20, 2001, 15 days after the submission was received.
What is the product code of K010640?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.