510(k) K022196 ยท LBI Unit, Neonatal Phototherapy
NATUS BLUE LIGHT PHOTOTHERAPY UNIT
| Applicant | Natus Medical, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Sep 19, 2002 |
| Received | Jul 5, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2017 | Natus Medical Incorporated 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.
Produc Terminated |
LBI | None listed |
| Apr 11, 2016 | Natus Medical Incorporated 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 tre Terminated |
LBI | None listed |
| Oct 21, 2015 | Natus Medical Incorporated Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103 Terminated |
LBI | None listed |
| Dec 22, 2014 | Natus Medical Incorporated Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy. Terminated |
LBI | None listed |
| Nov 24, 2009 | Natus Medical Incorporated The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System" Terminated |
LBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.