Cleared Traditional

MSI STANDARD BED MODELS: L1097-64 AND L1085-64

K881961 · Med Service, Inc. · General Hospital
Nov 1988
Decision
175d
Days
Class 1
Risk

About This 510(k) Submission

K881961 is an FDA 510(k) clearance for the MSI STANDARD BED MODELS: L1097-64 AND L1085-64, a Bed, Manual (Class I — General Controls, product code FNJ), submitted by Med Service, Inc. (Batesville, US). The FDA issued a Cleared decision on November 1, 1988, 175 days after receiving the submission on May 10, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5120.

Submission Details

510(k) Number K881961 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1988
Decision Date November 01, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FNJ — Bed, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5120