St/Ar ST and Arrhythmia Software, Release E.I.
FDA 510(k) K021251 · Philips Medical Systems
510(k) numberK021251
Submission
- Device name
- St/Ar ST and Arrhythmia Software, Release E.I.
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- April 19, 2002
- Decision date
- May 7, 2002
- 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 St/Ar ST and Arrhythmia Software, Release E.I. cleared by the FDA?
St/Ar ST and Arrhythmia Software, Release E.I. (K021251) received a 510(k) decision of Substantially Equivalent on May 7, 2002, 18 days after the submission was received.
What is the product code of K021251?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.