NightOwl— 510(k) K191031

Substantially Equivalent

Ectosense NV

FDA 510(k) clearance K191031 for NightOwl, Substantially Equivalent on 2020-03-06. Applicant: Ectosense NV.

Clearance details

Applicant: Ectosense NV
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2019-04-18
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rotselaar, BE

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