Cleared Traditional

ENVIROTENT (BED)

K881725 · Envirotents, Inc. · General Hospital

Nov 1988

Decision

200d

Days

Class 1

Risk

About This 510(k) Submission

K881725 is an FDA 510(k) clearance for the ENVIROTENT (BED), a Bed, Manual (Class I — General Controls, product code FNJ), submitted by Envirotents, Inc. (Denver, US). The FDA issued a Cleared decision on November 8, 1988, 200 days after receiving the submission on April 22, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5120.

Submission Details

510(k) Number	K881725 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1988
Decision Date	November 08, 1988
Days to Decision	200 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—