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510(k) K202837

GoSpiro by Monitored Therapeutics, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2020
Date Received
September 25, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Monitored Therapeutics, Inc.

  • K163249 — GoSpiro (March 24, 2017)

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