Cleared Traditional

K972115 - VOLKER HOSPITAL BED, MODEL K960
(FDA 510(k) Clearance)

K972115 · Volker Healthcare, Inc. · General Hospital

Aug 1997

Decision

85d

Days

Class 2

Risk

K972115 is an FDA 510(k) clearance for the VOLKER HOSPITAL BED, MODEL K960. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II — Special Controls, product code FNL).

Submitted by Volker Healthcare, Inc. (Great Neck,, US). The FDA issued a Cleared decision on August 29, 1997, 85 days after receiving the submission on June 5, 1997.

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

Submission Details

510(k) Number	K972115 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 1997
Decision Date	August 29, 1997
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement