510(k) K893624

PREEMICARE MODEL 2500 TRANSPORT WARMER by Preemicare Corp. — Product Code FPL

K893624 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE MODEL 2500 TRANSPORT WARMER". The FDA issued a decision of Substantially Equivalent on September 27, 1989. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Preemicare Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1989
Date Received
May 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal Transport
Device Class
Class II
Regulation Number
880.5410
Review Panel
HO
Submission Type