Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARDO Alyssa

K-Number: K212773 · 2022-04-15

ApplicantArdo Medical AG
Decision Date2022-04-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARDO Alyssa is a medical device manufactured by Ardo Medical AG. It received FDA 510(k) clearance on 2022-04-15 under approval number K212773. 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 ARDO Alyssa?

ARDO Alyssa is a medical device that received FDA 510(k) clearance on 2022-04-15. It is manufactured by Ardo Medical AG. The 510(k) number is K212773.

When was ARDO Alyssa approved by the FDA?

ARDO Alyssa received FDA 510(k) clearance on 2022-04-15, under approval number K212773.

What company makes ARDO Alyssa?

ARDO Alyssa is manufactured by Ardo Medical AG.

What is the FDA product code for ARDO Alyssa?

The FDA product code for ARDO Alyssa is HGX.

Other Devices by Ardo Medical AG

K172067One Mum Pumpset K230590ARDO Bellis

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.

↑