Panels › General Hospital › Product code LBI · Class 2
Unit, Neonatal Phototherapy
Regulation 880.5700
1510(k)s in 12 months (71 all time)
0recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in LBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Natus Medical Incorporated | 6 | 8 |
| Physician Engineered Products, Inc. | 6 | 1 |
| Olympic Medical Corp. | 6 | 0 |
| Ohmeda Medical | 3 | 1 |
| Air-Shields, Inc. | 3 | 0 |
| Draeger Medical Systems, Inc. | 2 | 1 |
| Lumitex, Inc. | 2 | 1 |
| Medix I.C.S.A. | 3 | 0 |
| Atom Medical Corporation | 2 | 0 |
| E & B Technologies, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2019 | Lumitex Inc Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M122506 Terminated |
LBI | K120820 |
| 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 | K022196 |
| Dec 15, 2016 | Natus Medical Incorporated Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Terminated |
LBI | K103589 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Spot PT
Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundic Terminated |
LBI | K011549 |
| Oct 28, 2016 | Natus Medical Incorporated Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia.
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad Terminated |
LBI | K103589 |
| 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 | K022196 |
| 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 | K022196 |
| Aug 31, 2015 | Physician Engineered Products, Inc. Bright Embrace, a Single Bili Light for newborn phototherapy
Distributed by: Physician Engineered Products, Inc., Model SBL60 Terminated |
LBI | K110550 |
| Apr 10, 2015 | Natus Medical Incorporated Natus neoBLUE blanket LED Phototherapy system which includes the following items:
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad
006254 neoBLUE blanket LED Light Box
006895 Terminated |
LBI | K103589 |
| 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 | K022196 |
| Jul 6, 2012 | Draeger Medical Systems, Inc. Drager PT 4000 Phototherapy System Terminated |
LBI | K954611 |
| 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 | K022196 |
| Nov 18, 2005 | Datex Ohmeda, Inc. dba GE Healthcare Ohmeda Giraffe SPOT PT Lite Phototherapy System Terminated |
LBI | None listed |
| Dec 18, 2003 | Fisher & Paykel Healthcare Inc Phototherapy Lamp, Model 9001W501JE Terminated |
LBI | None listed |
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