510(k) K770028

ENVIRONMENTAL CONTROL SYSTEMS by Possum, Inc. — Product Code IQA

K770028 is an FDA 510(k) premarket notification submitted by Possum, Inc. for the device "ENVIRONMENTAL CONTROL SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 12, 1977. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Possum, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1977
Date Received
January 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Environmental Control, Powered
Device Class
Class II
Regulation Number
890.3725
Review Panel
PM
Submission Type