NightOwl— 510(k) K191031
Substantially EquivalentEctosense NV
FDA 510(k) clearance K191031 for NightOwl, Substantially Equivalent on 2020-03-06. Applicant: Ectosense NV. Device class: 2.
Clearance details
- Applicant
- Ectosense NV
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rotselaar, BE
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