Taylor Long Term Monitoring Electrode
FDA 510(k) K941977 · Taylor Industries, Inc.
510(k) numberK941977
Submission
- Device name
- Taylor Long Term Monitoring Electrode
- Applicant
- Taylor Industries, Inc.
New Berlin, WI, US - Received
- April 19, 1994
- Decision date
- September 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Taylor Long Term Monitoring Electrode cleared by the FDA?
Taylor Long Term Monitoring Electrode (K941977) received a 510(k) decision of Substantially Equivalent on September 21, 1994, 155 days after the submission was received.
What is the product code of K941977?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.