FDA.reportPublic FDA data

510(k) K122689

Device
INOBLENDER
Applicant
INO THERAPEUTICS
510(k) number
K122689
Product code
MRO  
Decision
Substantially Equivalent (SESE)
Decision date
2012-11-07
Date received
2012-09-04
Regulation
868.5165
Classification name
Apparatus, Nitric Oxide, Backup Delivery
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT BOVY
Address
2902 Dairy Dr. Madison WI US 53718 53718

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
K052663INO THERAPEUTICS INOBLENDER, MODEL 10004Ino Therapeutics2005-11-04
K011874FADASIS MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.2001-07-20
K003665FADASSI MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.2001-02-23

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases