510(k) K121661

Device
EZ-ASSIST-FILL
Applicant
ASSIST FILL, LLC
510(k) number
K121661
Product code
PCM  
Decision
Substantially Equivalent (SESE)
Decision date
2012-12-27
Date received
2012-06-05
Regulation
890.5050
Classification name
Portable Liquid Oxygen Unit Stand
Medical specialty
Physical Medicine
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GRIFFIN
Address
55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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