Cleared Traditional

K875037 - STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED (FDA 510(k) Clearance)

Feb 1988
Decision
66d
Days
Class 2
Risk

K875037 is an FDA 510(k) clearance for the STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on February 11, 1988, 66 days after receiving the submission on December 7, 1987.

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

Submission Details

510(k) Number K875037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date February 11, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

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