Bard Neonatal ECG Monitoring Electrode
FDA 510(k) K891075 · C.R. Bard, Inc.
510(k) numberK891075
Submission
- Device name
- Bard Neonatal ECG Monitoring Electrode
- Applicant
- C.R. Bard, Inc.
Tewksbury, MA, US - Received
- March 1, 1989
- Decision date
- March 22, 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 Bard Neonatal ECG Monitoring Electrode cleared by the FDA?
Bard Neonatal ECG Monitoring Electrode (K891075) received a 510(k) decision of Substantially Equivalent on March 22, 1989, 21 days after the submission was received.
What is the product code of K891075?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.