1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K023793
Device Name 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
Original Applicant
PORTEX, INC.
10 bowman dr.
keene, 
NH 
03431

Original Contact cindy engelhardt
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 11/13/2002
Decision Date 02/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No