Philips Avent Comfort Single/Twin Electric Breast Pump

Pump, Breast, Powered

Philips Consumer Lifestyle-Innovation Site Eindhoven

The following data is part of a premarket notification filed by Philips Consumer Lifestyle-innovation Site Eindhoven with the FDA for Philips Avent Comfort Single/twin Electric Breast Pump.

Pre-market Notification Details

Device IDK161532
510k NumberK161532
Device Name:Philips Avent Comfort Single/Twin Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Philips Consumer Lifestyle-Innovation Site Eindhoven High Tech Campus 37 Eindhoven,  NL 5656 Ae
ContactMarta Walker
CorrespondentMarta Walker
Philips Consumer Lifestyle-Innovation Site Eindhoven High Tech Campus 37 Eindhoven,  NL 5656 Ae
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-02
Decision Date2016-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00075020070111 K161532 000
00075020070104 K161532 000
00075020070098 K161532 000
00075020070081 K161532 000
00075020070074 K161532 000

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