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510(k) K203378

Pulsehaler by Respinova, Ltd. — Product Code BWF

K203378 is an FDA 510(k) premarket notification submitted by Respinova, Ltd. for the device "Pulsehaler". The FDA issued a decision of Substantially Equivalent on March 31, 2021. 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
March 31, 2021
Date Received
November 17, 2020
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