510(k) K862628

BUNN MODEL 510 MEDICATION COMPRESSOR by The John Bunn Co. — Product Code BTI

K862628 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN MODEL 510 MEDICATION COMPRESSOR". The FDA issued a decision of Substantially Equivalent on August 7, 1986. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1986
Date Received
July 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type