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)

ANCORIS

K-Number: K201807 · 2020-08-27

ApplicantMiegmbh
Decision Date2020-08-27
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANCORIS is a medical device manufactured by Miegmbh. It received FDA 510(k) clearance on 2020-08-27 under approval number K201807. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCORIS?

ANCORIS is a medical device that received FDA 510(k) clearance on 2020-08-27. It is manufactured by Miegmbh. The 510(k) number is K201807.

When was ANCORIS approved by the FDA?

ANCORIS received FDA 510(k) clearance on 2020-08-27, under approval number K201807.

What company makes ANCORIS?

ANCORIS is manufactured by Miegmbh.

What is the FDA product code for ANCORIS?

The FDA product code for ANCORIS is KPS.

Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

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.

↑