510(k) K093126

Device
ANAPNOGUARD ENDOTRACHEAL TUBE
Applicant
HOSPITECH RESPIRATION LTD.
510(k) number
K093126
Product code
BTP  
Decision
Substantially Equivalent (SESE)
Decision date
2010-03-02
Date received
2009-10-02
Regulation
868.5420
Classification name
Dropper, Ether
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
YORAM LEVY
Address
31 Haavoda St. Binyamina IL 30500 30500

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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