Incubator, Neonatal Transport

Device Code: 2583

Product Code(s): FPL

Device Classification Information

• Device Type ID: 2583
• Device Name: Incubator, Neonatal Transport
• Regulation Description: Neonatal Transport Incubator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5410 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FPL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-386 IEC 60601-2-20 Edition 2.1 2016-04
  CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-20: Particular Requirements For The Basic Safety And Essential Performance Of Infant Transport Incubators [Including: Amendment 1 (2016)]

Total Product Life Cycle

• Device Type ID: 2583
• Device: Incubator, Neonatal Transport
• Product Code: FPL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Neonatal Transport Incubator.
• CFR Regulation Number: 880.5410 [🔎]

Premarket Reviews
Manufacturer	Decision
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:15:18