VIVACE
K-Number: K242111 · 2025-02-06
ApplicantUnimom.Co
Decision Date2025-02-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
VIVACE is a medical device manufactured by Unimom.Co. It received FDA 510(k) clearance on 2025-02-06 under approval number K242111. 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 VIVACE?
VIVACE is a medical device that received FDA 510(k) clearance on 2025-02-06. It is manufactured by Unimom.Co. The 510(k) number is K242111.
When was VIVACE approved by the FDA?
VIVACE received FDA 510(k) clearance on 2025-02-06, under approval number K242111.
What company makes VIVACE?
VIVACE is manufactured by Unimom.Co.
What is the FDA product code for VIVACE?
The FDA product code for VIVACE is HGX.
Other Devices by Unimom.Co
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.