E.S TECK (Electro Sensor Teck)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083229 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The E.S TECK (Electro Sensor Teck) is a physiological patient monitor without arrhythmia detection or alarms, classified under product code MWI and regulation 870.2300. It is designed for cardiovascular monitoring and provides measurements related to heart rate variability, pulse oximetry, and photoelectrical plethysmography.
The device was cleared through the FDA 510(k) process under K083229 on February 23, 2009, as substantially equivalent to a predicate device. It is manufactured by LD Technology, LLC in Miami, Florida, and is intended for use in clinical settings where non-invasive physiological monitoring is required.
Frequently asked questions
What is the E.S TECK used for?
The E.S TECK is designed for cardiovascular monitoring and provides measurements related to heart rate variability, pulse oximetry, and photoelectrical plethysmography in clinical settings requiring non-invasive physiological monitoring.
Does the E.S TECK include arrhythmia detection or alarms?
No, the E.S TECK is specifically classified as a physiological patient monitor without arrhythmia detection or alarms, as stated in its description and product code MWI classification.
How was the E.S TECK cleared for market?
The E.S TECK was cleared through the FDA 510(k) process under K083229 on February 23, 2009, as substantially equivalent to a predicate device.
Who manufactures the E.S TECK and where is it made?
The E.S TECK is manufactured by LD Technology, LLC in Miami, Florida, at their facility located at 11459 NW 34 St., Miami, FL 33178.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: E.S TECK ( ELECTRO SENSOR TECK) (K083229) — FDA 510 (k) | Innolitics, E.S TECK ( ELECTRO SENSOR TECK) 510(k) K083229 - FDA.report, PDF L.D Technology LLC. - Food and Drug Administration, L.D. Technology, LLC - Miami, Florida (FL) @ MedicRegister.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083229 | Class II | Active |
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Manufacturer
- Manufacturer
- Ld Technology, Llc
Sources (1)
- FDA 510(k) K083229 24 fields · synced Sep 22, 2026