Cleared Traditional

K926140 - VACUUM POWER BODY FLUID SUCTION APPARATUS (FDA 510(k) Clearance)

Jul 1993
Decision
232d
Days
Class 2
Risk

K926140 is an FDA 510(k) clearance for the VACUUM POWER BODY FLUID SUCTION APPARATUS. This device is classified as a Regulator, Vacuum (Class II - Special Controls, product code KDP).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on July 27, 1993, 232 days after receiving the submission on December 7, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K926140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1992
Decision Date July 27, 1993
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KDP — Regulator, Vacuum
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6740