Stand. Clear Vinyl Disposable ECG ELECT.(597 Adhe)
FDA 510(k) K872869 · Labeltape Meditect, Inc.
510(k) numberK872869
Submission
- Device name
- Stand. Clear Vinyl Disposable ECG ELECT.(597 Adhe)
- Applicant
- Labeltape Meditect, Inc.
Grand Rapids, MI, US - Received
- July 21, 1987
- Decision date
- November 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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| K896936 | L.A.S.P. Lumbar and Sacral Pad, Reposition. SnapGXY · Traditional | 01/22/1990SE |
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Questions and answers
When was Stand. Clear Vinyl Disposable ECG ELECT.(597 Adhe) cleared by the FDA?
Stand. Clear Vinyl Disposable ECG ELECT.(597 Adhe) (K872869) received a 510(k) decision of Substantially Equivalent on November 4, 1987, 106 days after the submission was received.
What is the product code of K872869?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.