Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter
FDA 510(k) K033807 · Draeger Medical Systems, Inc.
510(k) numberK033807
Submission
- Device name
- Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter
- Applicant
- Draeger Medical Systems, Inc.
Danvers, MA, US - Received
- December 8, 2003
- Decision date
- March 9, 2004
- 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 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter cleared by the FDA?
Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter (K033807) received a 510(k) decision of Substantially Equivalent on March 9, 2004, 92 days after the submission was received.
What is the product code of K033807?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.