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510(k) K940927

Device
RESCUE BREATHER
Applicant
O-TWO SYSTEMS INTL., INC.
510(k) number
K940927
Product code
LYM  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-14
Date received
1994-02-28
Regulation
510(k) Premarket Notification
Classification name
Device, Cpr Assist
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEVIN BOWDEN
Address
7575 Kimbel St. Mississauga CA L5S 1C8 L5S 1C8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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