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Mri Compatible Patient Monitoring System, Model 865214

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090785

by Invivo Corp.

Identifiers

510(k) Number
K090785 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)

Mri Compatible Patient Monitoring System, Model 865214 by Invivo Corp. — 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
Invivo Corp.

Sources (1)

  • FDA 510(k) K090785 24 fields · synced Jun 18, 2026