Mac 5000 ECG Analysis System
FDA 510(k) K014108 · General Electric Medical Systems Information Techn
510(k) numberK014108
Submission
- Device name
- Mac 5000 ECG Analysis System
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- December 13, 2001
- Decision date
- January 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 Mac 5000 ECG Analysis System cleared by the FDA?
Mac 5000 ECG Analysis System (K014108) received a 510(k) decision of Substantially Equivalent on January 10, 2002, 28 days after the submission was received.
What is the product code of K014108?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.