FDA.reportPublic FDA data

510(k) K011565

Device
INFANT OXYGEN TREATMENT HOOD
Applicant
Gulf Coast Hyperbarics, Inc.
510(k) number
K011565
Product code
CBF
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-16
Date received
2001-05-21
Regulation
868.5470
Classification name
Chamber, Hyperbaric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
JAMES W MCCARTHY
Address
4309 Green Leaf Cir. Panama City FL US 32404 32404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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