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)

HS AMICA devices family

K-Number: K182605 · 2019-10-28

ApplicantH.S Hospital Service S.P.A
Decision Date2019-10-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HS AMICA devices family is a medical device manufactured by H.S Hospital Service S.P.A. It received FDA 510(k) clearance on 2019-10-28 under approval number K182605. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HS AMICA devices family?

HS AMICA devices family is a medical device that received FDA 510(k) clearance on 2019-10-28. It is manufactured by H.S Hospital Service S.P.A. The 510(k) number is K182605.

When was HS AMICA devices family approved by the FDA?

HS AMICA devices family received FDA 510(k) clearance on 2019-10-28, under approval number K182605.

What company makes HS AMICA devices family?

HS AMICA devices family is manufactured by H.S Hospital Service S.P.A.

What is the FDA product code for HS AMICA devices family?

The FDA product code for HS AMICA devices family is GEI.

Related Clinical Trials

NCT05264389 Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction ACTIVE_NOT_RECRUITING NCT06271577 Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II RECRUITING NCT07519369 Monitoring Daily Mobility in Children With Autism RECRUITING NCT07384650 Post-stroke Nurse-led Rehabilitation to Improve Functional Activity and Community Participation in Bangladesh RECRUITING

Other Devices by H.S Hospital Service S.P.A

K242029TRAP EASY K232072AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑