Fit Pro Breast Pump
K-Number: K212955 · 2022-03-15
ApplicantHygeia II Medical Group, Inc.
Decision Date2022-03-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Fit Pro Breast Pump is a medical device manufactured by Hygeia II Medical Group, Inc.. It received FDA 510(k) clearance on 2022-03-15 under approval number K212955. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fit Pro Breast Pump?
Fit Pro Breast Pump is a medical device that received FDA 510(k) clearance on 2022-03-15. It is manufactured by Hygeia II Medical Group, Inc.. The 510(k) number is K212955.
When was Fit Pro Breast Pump approved by the FDA?
Fit Pro Breast Pump received FDA 510(k) clearance on 2022-03-15, under approval number K212955.
What company makes Fit Pro Breast Pump?
Fit Pro Breast Pump is manufactured by Hygeia II Medical Group, Inc..
What is the FDA product code for Fit Pro Breast Pump?
The FDA product code for Fit Pro Breast Pump is HGX.
Other Devices by Hygeia II Medical Group, Inc.
Related Devices (Code: HGX)
K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd.
K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc.
K160274Hi bebe plusBistos Co., Ltd.
K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven
K161266Athena Breast PumpExploramed Nc7, Inc.
K160511Naya Breast Pump SystemNaya Health, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.