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INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS - delta

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 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