Cleared Traditional

K924420 - MEDICAL DISPOSABLE BEDDING (FDA 510(k) Clearance)

Dec 1993
Decision
465d
Days
Class 2
Risk

K924420 is an FDA 510(k) clearance for the MEDICAL DISPOSABLE BEDDING. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on December 10, 1993, 465 days after receiving the submission on September 1, 1992.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.

Submission Details

510(k) Number K924420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date December 10, 1993
Days to Decision 465 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code KNC — Table, Obstetric (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.4900