QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)
FDA 510(k) K981024 · Marquette Medical Systems, Inc.
510(k) numberK981024
Submission
- Device name
- QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)
- Applicant
- Marquette Medical Systems, Inc.
Milwaukee, WI, US - Received
- March 19, 1998
- Decision date
- October 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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Questions and answers
When was QT Dispersion and T Wave Analysis Program (QT Guard Analysis System) cleared by the FDA?
QT Dispersion and T Wave Analysis Program (QT Guard Analysis System) (K981024) received a 510(k) decision of Substantially Equivalent on October 6, 1998, 201 days after the submission was received.