Cleared Traditional

K931482 - STRYKER MPS ACUTE CARE BED (FDA 510(k) Clearance)

Sep 1993
Decision
169d
Days
Class 2
Risk

K931482 is an FDA 510(k) clearance for the STRYKER MPS ACUTE CARE BED. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on September 9, 1993, 169 days after receiving the submission on March 24, 1993.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number K931482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date September 09, 1993
Days to Decision 169 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FNL — Bed, Ac-powered Adjustable Hospital
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5100