WVSM (Wireless Vital Signs Monitor) RWC + MiniCap

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Athena GTX

The following data is part of a premarket notification filed by Athena Gtx with the FDA for Wvsm (wireless Vital Signs Monitor) Rwc + Minicap.

Pre-market Notification Details

Device IDK191989
510k NumberK191989
Device Name:WVSM (Wireless Vital Signs Monitor) RWC + MiniCap
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Athena GTX 5900 NW 86th Street, Suite 300 Johnston,  IA  50131
ContactSean Mahoney
CorrespondentSean Mahoney
Athena GTX 5900 NW 86th Street, Suite 300 Johnston,  IA  50131
Product CodeMWI  
Subsequent Product CodeCCK
Subsequent Product CodeDQA
Subsequent Product CodeDRG
Subsequent Product CodeDXN
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-25
Decision Date2020-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B3945700047020 K191989 000
B3945700047010 K191989 000
B394530023020 K191989 000
B3945300023010 K191989 000
B3945000034040 K191989 000
B3945000034030 K191989 000
B3945000034020 K191989 000
B3945000034010 K191989 000
B3944670019010 K191989 000

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