Cleared Traditional

STRYKER AGILITY INTENSIVE CARE BED

K946149 · Stryker Medical · General Hospital
Mar 1995
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K946149 is an FDA 510(k) clearance for the STRYKER AGILITY INTENSIVE CARE BED, a Bed, Ac-powered Adjustable Hospital (Class II — Special Controls, product code FNL), submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on March 14, 1995, 88 days after receiving the submission on December 16, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number K946149 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1994
Decision Date March 14, 1995
Days to Decision 88 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

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