Steth IO Spot— 510(k) K220196

Substantially Equivalent

Stratoscientific

FDA 510(k) clearance K220196 for Steth IO Spot, Substantially Equivalent on 2022-03-24. Applicant: Stratoscientific. Device class: 2.

Clearance details

Applicant
Stratoscientific
Product code
Code DQD
Device class
Class 2
Regulation
21 CFR 870.1875
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bothell, WA, US
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