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#
- 3020831613
- 3007682555
Source Documents#
Legacy Summary#
summary
FDA Review#
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