NightOwl— 510(k) K220028

Substantially Equivalent

Ectosense NV

FDA 510(k) clearance K220028 for NightOwl, Substantially Equivalent on 2022-02-24. Applicant: Ectosense NV.

Clearance details

Applicant: Ectosense NV
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2022-01-05
Decision date: 2022-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Rotselaar, BE

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