Cleared Traditional

K780230 - BED BOARD (FDA 510(k) Clearance)

K780230 · Biomet, Inc. · General Hospital

Feb 1978

Decision

19d

Days

Class 1

Risk

K780230 is an FDA 510(k) clearance for the BED BOARD. This device is classified as a Board, Bed (Class I - General Controls, product code FPS).

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978, 19 days after receiving the submission on February 9, 1978.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6070.

Submission Details

510(k) Number	K780230 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 1978
Decision Date	February 28, 1978
Days to Decision	19 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

Device Classification

Product Code	FPS — Board, Bed
Device Class	Class I - General Controls
CFR Regulation	21 CFR 880.6070