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Infinity Modular Monitors With Vf5 Modifications (delta +6 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043439

by Draeger Medical Systems, Inc.

Identifiers

510(k) Number
K043439 FDA 510(k)
FDA Product Code
MHX FDA 510(k)
Models / Variants
delta FDA 510(k)
Kappa FDA 510(k)
Delta Xl FDA 510(k)
Vista Xl FDA 510(k)
Gamma X Xl And Sc 7000 FDA 510(k)
8000 FDA 510(k)
9000xl FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Infinity Modular Monitors With Vf5 Modifications (delta +6 more) by Draeger Medical Systems, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 7 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Draeger Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K043439 24 fields · synced Jun 18, 2026