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510(k) K141355

VOLUMETRIC INCENTIVE SPIROMETER by Besmed Health Business Corporation — Product Code BWF

K141355 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corporation for the device "VOLUMETRIC INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on September 3, 2014. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2014
Date Received
May 23, 2014
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

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FDA data resources