PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR


Device Classification Name

tube, tracheostomy (w/wo connector)

510(k) Number K073702
Device Name PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
Applicant
LAZARUS MEDICAL LLC
2129 beneventum ct
raleigh, 
NC 
27606

Applicant Contact cynthia j.m nolte
Correspondent
LAZARUS MEDICAL LLC
2129 beneventum ct
raleigh, 
NC 
27606

Correspodent Contact cynthia j.m nolte
Regulation Number 868.5800
Classification Product Code
BTO  
Date Received 12/31/2007
Decision Date 06/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No