510(k) K900314

PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN by Percussionaire Corp. — Product Code CBK

K900314 is an FDA 510(k) premarket notification submitted by Percussionaire Corp. for the device "PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN". The FDA issued a decision of SN on October 26, 1990. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Percussionaire Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 26, 1990
Date Received
January 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type