neoBLUE® LED Phototherapy System— 510(k) K160305
Substantially EquivalentNatus Medical Incorporated
FDA 510(k) clearance K160305 for neoBLUE® LED Phototherapy System, Substantially Equivalent on 2016-05-27. Applicant: Natus Medical Incorporated. Device class: 2.
Clearance details
- Applicant
- Natus Medical Incorporated
- Product code
- Code LBI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5700
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code LBI
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view all- K182178 — neoBLUE blanket LED Phototherapy System
- K182263 — RetCam 3; RetCam Shuttle; RetCam Portable
- K160745 — neoBLUE compact LED Phototherapy System
- K143440 — Natus Quantum
- K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
Data sourced from openFDA. This site is unofficial and independent of the FDA.