APEX MEDICAL CPAP RT 21XX


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K022650
Device Name APEX MEDICAL CPAP RT 21XX
Original Applicant
APEX MEDICAL CORP.
10th fl., no. 31, lane 169,
kang ning st.
shi-chih, taipei hsien, 

TW

Original Contact alan chang
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 08/09/2002
Decision Date 02/04/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No