APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K112079
Device Name APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
Applicant
APEX MEDICAL CORP.
no. 9, minsheng street
tucheng city, taipei county, 

TW

236

Applicant Contact alan chang
Correspondent
APEX MEDICAL CORP.
no. 9, minsheng street
tucheng city, taipei county, 

TW

236

Correspodent Contact alan chang
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 07/21/2011
Decision Date 12/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No