510(k) K802067

CLEAN-AIR POLLUTION REDUCTION SYSTEM by Porter Instrument Co., Inc. — Product Code CBN

K802067 is an FDA 510(k) premarket notification submitted by Porter Instrument Co., Inc. for the device "CLEAN-AIR POLLUTION REDUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 1980. 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
September 26, 1980
Date Received
August 27, 1980
Clearance Type
Traditional
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