NATUS BLUE LIGHT PHOTOTHERAPY UNIT— 510(k) K022196
Substantially EquivalentNatus Medical, Inc.
FDA 510(k) clearance K022196 for NATUS BLUE LIGHT PHOTOTHERAPY UNIT, Substantially Equivalent on 2002-09-19. Applicant: Natus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Natus Medical, Inc.
- 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
- San Carlos, CA, US
Recent devices under product code LBI
view allMore clearances from Natus Medical, Inc.
view allRecalls naming K022196
K-number listed on FDA's recall record- Z-1924-2017 — Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
- Z-2001-2016 — Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
- Z-0149-2016 — Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
- Z-0847-2015 — Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022196.
Data sourced from openFDA. This site is unofficial and independent of the FDA.