INFOSEND GSM


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K110316
Device Name INFOSEND GSM
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place,
east tamaki
auckland, 

NZ

1701

Applicant Contact james thompson
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place,
east tamaki
auckland, 

NZ

1701

Correspodent Contact james thompson
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 02/03/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No