Mactrode 3
FDA 510(k) K060661 · Ge Medical Systems Information Technologies
510(k) numberK060661
Submission
- Device name
- Mactrode 3
- Applicant
- Ge Medical Systems Information Technologies
Milwaukee, WI, US - Received
- March 13, 2006
- Decision date
- April 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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Questions and answers
When was Mactrode 3 cleared by the FDA?
Mactrode 3 (K060661) received a 510(k) decision of Substantially Equivalent on April 7, 2006, 25 days after the submission was received.
What is the product code of K060661?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.