510(k) K981754

AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 by Porter Instrument Co., Inc. — Product Code CBN

K981754 is an FDA 510(k) premarket notification submitted by Porter Instrument Co., Inc. for the device "AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000". The FDA issued a decision of Substantially Equivalent on June 16, 1998. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Porter Instrument Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1998
Date Received
May 18, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type