TRIBALL INCENTIVE SPIROMETER

Spirometer, Therapeutic (incentive)

BESMED HEALTH BUSINESS CORP.

The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Triball Incentive Spirometer.

Pre-market Notification Details

Device IDK133873
510k NumberK133873
Device Name:TRIBALL INCENTIVE SPIROMETER
ClassificationSpirometer, Therapeutic (incentive)
Applicant BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, Wu-ku District,  TW Taiwan
ContactPaul Dryden
CorrespondentPaul Dryden
BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD New Taipei City, Wu-ku District,  TW Taiwan
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-20
Decision Date2014-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04716770931005 K133873 000
04716770342108 K133873 000
40612479269956 K133873 000

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