Cleared Special

AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000

K981754 · Porter Instrument Co., Inc. · Anesthesiology

Jun 1998

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K981754 is an FDA 510(k) clearance for the AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Porter Instrument Co., Inc. (Hatfield, US). The FDA issued a Cleared decision on June 16, 1998, 29 days after receiving the submission on May 18, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number	K981754 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1998
Decision Date	June 16, 1998
Days to Decision	29 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF