FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT

K Number: K931346 · Decision Aug 25, 1993
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
24
Applicant Total
5
Review Days
161

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Basic Information

Device Name
FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
K Number
K931346
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5410
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Ferno
Date Received
March 17, 1993
Decision Date
August 25, 1993
Product Code
FPL
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FPL Incubator, Neonatal Transport

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K Number Device Name
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K924023 FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
K914125 FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403