NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
FDA 510(k) clearance K103589 · decided 2011-05-13
Clearance details
- K-number
- K103589
- Device name
- NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
- Applicant
- Natus Medical Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2010-12-07
- Decision date
- 2011-05-13
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- LBI
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneat recall (Z-0769-2017) | Natus Medical Incorporated | 2016-12-15 |
| Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 n recall (Z-1412-2015) | Natus Medical Incorporated | 2015-04-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OLYMPIC COOL-CAP SYSTEM (P040025/S014) | Natus Medical Incorporated | 2013-12-23 |
| OLYMPIC COOL CAP (P040025/S013) | Natus Medical Incorporated | 2013-08-29 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S012) | Natus Medical Incorporated | 2012-03-27 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S011) | Natus Medical Incorporated | 2010-11-23 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S010) | Natus Medical Incorporated | 2010-06-28 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S009) | Natus Medical Incorporated | 2009-09-18 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S007) | Natus Medical Incorporated | 2009-04-22 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S008) | Natus Medical Incorporated | 2008-12-24 |