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Spectramed Disposable Transducer (dt-Xxo) & Access

FDA 510(k)

Class II (US FDA 510(k))

510(k) K873168

by Spectramed, Inc.

Identifiers

510(k) Number
K873168 FDA 510(k)
FDA Product Code
DRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2850 FDA 510(k)
Regulation Number
870.2850 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Spectramed Disposable Transducer (dt-Xxo) & Access by Spectramed, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spectramed, Inc.

Sources (1)

  • FDA 510(k) K873168 24 fields · synced Jun 18, 2026