Medilog Excel ECG Analysis System (Modified)
FDA 510(k) K920295 · Oxford Medilog, Inc.
510(k) numberK920295
Submission
- Device name
- Medilog Excel ECG Analysis System (Modified)
- Applicant
- Oxford Medilog, Inc.
Clearwater, FL, US - Received
- January 22, 1992
- Decision date
- August 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Medilog Excel ECG Analysis System (Modified) cleared by the FDA?
Medilog Excel ECG Analysis System (Modified) (K920295) received a 510(k) decision of Substantially Equivalent on August 18, 1992, 209 days after the submission was received.
What is the product code of K920295?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.