Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications
FDA 510(k) K031433 · Siemens Medical Solutions USA, Inc.
510(k) numberK031433
Submission
- Device name
- Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications
- Applicant
- Siemens Medical Solutions USA, Inc.
Danvers, MA, US - Received
- May 6, 2003
- Decision date
- August 19, 2003
- 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 Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications cleared by the FDA?
Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications (K031433) received a 510(k) decision of Substantially Equivalent on August 19, 2003, 105 days after the submission was received.
What is the product code of K031433?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.