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510(k) K200698

Device
Somnera System
Applicant
FRESCA Medical Inc.
510(k) number
K200698
Product code
QBY  
Decision
Substantially Equivalent (SESE)
Decision date
2020-06-29
Date received
2020-03-17
Regulation
868.5273
Classification name
Positive Airway Pressure System
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mary Lou Mooney
Address
1291 Puerta Del Sol Suite #200 San Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QBY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN170089Curve Positive Airway Pressure SystemFresca Medical2018-06-05

Legacy Summary#

summary

FDA Review#

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