NightOwl— 510(k) K213463

Substantially Equivalent

Ectosense NV

FDA 510(k) clearance K213463 for NightOwl, Substantially Equivalent on 2021-12-16. Applicant: Ectosense NV.

Clearance details

Applicant: Ectosense NV
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2021-10-27
Decision date: 2021-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Rotselaar, BE

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