510(k) K834292

PALL HEAT MOISTURE EXCHANGING FILTER by Pall Biomedical Products Co. — Product Code BYD

K834292 is an FDA 510(k) premarket notification submitted by Pall Biomedical Products Co. for the device "PALL HEAT MOISTURE EXCHANGING FILTER". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Pall Biomedical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
December 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
Review Panel
AN
Submission Type