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STS RANGE - Sts20

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012008

by Huntleigh Healthcare Limited

Identifiers

510(k) Number
K012008 FDA 510(k)
FDA Product Code
JOW FDA 510(k)
Models / Variants
Sts20 FDA 510(k)
Sts30 FDA 510(k)
Sts40 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5800 FDA 510(k)
Regulation Number
870.5800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

STS RANGE - Sts20 by Huntleigh Healthcare Limited — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Huntleigh Healthcare Limited
FDA Applicant
Huntleigh Healthcare, Inc.

Sources (1)

  • FDA 510(k) K012008 24 fields · synced Jun 18, 2026