APEX MEDICAL XT AUTO CPAP 9S-005200

Ventilator, Non-continuous (respirator)

APEX MEDICAL CORP.

The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Apex Medical Xt Auto Cpap 9s-005200.

Pre-market Notification Details

Device IDK083656
510k NumberK083656
Device Name:APEX MEDICAL XT AUTO CPAP 9S-005200
ClassificationVentilator, Non-continuous (respirator)
Applicant APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County,  TW 236
ContactAlan Chang
CorrespondentAlan Chang
APEX MEDICAL CORP. NO. 9, MINSHENG STREET Tucheng City, Taipei County,  TW 236
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-10
Decision Date2009-04-22
Summary:summary

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