510(k) K931346

FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT by Ferno — Product Code FPL

K931346 is an FDA 510(k) premarket notification submitted by Ferno for the device "FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Ferno has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1993
Date Received
March 17, 1993
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