Spectra Q
K-Number: K191109 · 2020-01-22
ApplicantUzinmedicare Co.
Decision Date2020-01-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Spectra Q is a medical device manufactured by Uzinmedicare Co.. It received FDA 510(k) clearance on 2020-01-22 under approval number K191109. 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 Spectra Q?
Spectra Q is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by Uzinmedicare Co.. The 510(k) number is K191109.
When was Spectra Q approved by the FDA?
Spectra Q received FDA 510(k) clearance on 2020-01-22, under approval number K191109.
What company makes Spectra Q?
Spectra Q is manufactured by Uzinmedicare Co..
What is the FDA product code for Spectra Q?
The FDA product code for Spectra Q is HGX.
Other Devices by Uzinmedicare 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.