510(k) K133873

TRIBALL INCENTIVE SPIROMETER by Besmed Health Business Corp — Product Code BWF

K133873 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "TRIBALL INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on April 4, 2014. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2014
Date Received
December 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type