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Philips Spo2 Reusable Sensor, Models M1196a And M1196t

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062605

by Philips Medical Systems

Identifiers

510(k) Number
K062605 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Philips Spo2 Reusable Sensor, Models M1196a And M1196t by Philips Medical Systems — 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

Sources (1)

  • FDA 510(k) K062605 24 fields · synced Jun 18, 2026