Baby Mac Electrocardiograph Electrode
FDA 510(k) K895834 · Marquette Electronics, Inc.
510(k) numberK895834
Submission
- Device name
- Baby Mac Electrocardiograph Electrode
- Applicant
- Marquette Electronics, Inc.
Jupiter, FL, US - Received
- October 2, 1989
- Decision date
- November 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Baby Mac Electrocardiograph Electrode cleared by the FDA?
Baby Mac Electrocardiograph Electrode (K895834) received a 510(k) decision of Substantially Equivalent on November 3, 1989, 32 days after the submission was received.
What is the product code of K895834?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.