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Pedicraft Bassinet

FDA 510(k)

Class II (US FDA 510(k))

510(k) K925949

by Pedicraft, Inc.

Identifiers

510(k) Number
K925949 FDA 510(k)
FDA Product Code
FMS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5140 FDA 510(k)
Regulation Number
880.5140 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pedicraft Bassinet is a pediatric open hospital bed designed for infant care. It is constructed of stainless steel and features a cabinet with a removable shelf for storage.

This device is supplied with 4-inch casters and an acrylic component. It has received FDA 510k clearance under regulation number 880.5140.

Frequently asked questions

What is the intended use of the Pedicraft Bassinet?

The Pedicraft Bassinet is designed as an open hospital bed specifically for the care of infants in a clinical environment.

What are the primary construction materials and features of this bed?

This device is constructed from stainless steel and includes an acrylic component. It is equipped with 4-inch casters for mobility and a built-in cabinet with a removable shelf to provide storage space for infant care supplies.

What is the regulatory status of the Pedicraft Bassinet?

The Pedicraft Bassinet has received FDA 510k clearance under regulation number 880.5140, which classifies it as a pediatric open hospital bed.

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: Pedicraft Bassinet with Cabinet, Pedicraft: Bassinets with Drawers, Cabinets, Storage Bins and Acrylic ..., Pedicraft: Made Entirely in USA:Field Hospital Beds,Triage Isolation ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pedicraft, Inc.

Sources (1)

  • FDA 510(k) K925949 24 fields · synced Sep 22, 2026