Siemens Infinity Mib II Duo Protocol Converter
FDA 510(k) K012461 · Siemens Medical Solutions USA, Inc.
510(k) numberK012461
Submission
- Device name
- Siemens Infinity Mib II Duo Protocol Converter
- Applicant
- Siemens Medical Solutions USA, Inc.
Danvers, MA, US - Received
- August 1, 2001
- Decision date
- August 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Siemens Infinity Mib II Duo Protocol Converter cleared by the FDA?
Siemens Infinity Mib II Duo Protocol Converter (K012461) received a 510(k) decision of Substantially Equivalent on August 17, 2001, 16 days after the submission was received.
What is the product code of K012461?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.