← Back to catalogue

Diagnostic Station DS20

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152043

by Schiller AG

Identifiers

510(k) Number
K152043 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Diagnostic Station DS20 by Schiller AG — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Schiller AG

Sources (1)

  • FDA 510(k) K152043 24 fields · synced Jun 18, 2026