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510(k) K003665

Device
FADASSI MEDICAL FM-1 NO BLENDER
Applicant
FADASIS MEDICAL, INC.
510(k) number
K003665
Product code
MRO  
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-23
Date received
2000-11-28
Regulation
868.5165
Classification name
Apparatus, Nitric Oxide, Backup Delivery
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND RIDDLE
Address
7601-B Murphy Dr. Middleton WI US 53562 53562

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122689INOBLENDERIno Therapeutics2012-11-07
K052663INO THERAPEUTICS INOBLENDER, MODEL 10004Ino Therapeutics2005-11-04
K011874FADASIS MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.2001-07-20

Legacy Summary#

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FDA Review#

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