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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K220111
Device Name RespiraSense
Applicant
PMD Solutions
Bishopstown House Model Farm Rd
Cork,  IE T12 T922
Applicant Contact Sinead O'Sullivan
Correspondent
ProMedic Consulting LLC
131 Bay Point Dr NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received01/13/2022
Decision Date 10/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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