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Piconibp Oem Module

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051366

by Philips Medizin Systeme Boeblingen GmbH

Identifiers

510(k) Number
K051366 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PICONIBP OEM MODULE is a non-invasive blood pressure measurement system classified under the cardiovascular specialty. It is designed as an original equipment manufacturer module for integration into larger medical devices.

The device received FDA 510(k) clearance (K051366) on September 14, 2005, and was found substantially equivalent to a predicate device. It is manufactured by Philips Medizin Systeme Boeblingen GmbH and assigned product code DXN.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K051366 - PICONIBP OEM MODULE | FDA 510 (k), PICONIBP OEM MODULE (K051366) — FDA 510 (k) | Innolitics, PICONIBP OEM MODULE 510 (k) K051366 - FDA.report, PDF SEP 1 4 2005 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medizin Systeme Boeblingen GmbH

Sources (1)

  • FDA 510(k) K051366 24 fields · synced Oct 6, 2026