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)

NAVIRFA Scope

K-Number: K211529 · 2022-05-05

ApplicantNavifus Corporation
Decision Date2022-05-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NAVIRFA Scope is a medical device manufactured by Navifus Corporation. It received FDA 510(k) clearance on 2022-05-05 under approval number K211529. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIRFA Scope?

NAVIRFA Scope is a medical device that received FDA 510(k) clearance on 2022-05-05. It is manufactured by Navifus Corporation. The 510(k) number is K211529.

When was NAVIRFA Scope approved by the FDA?

NAVIRFA Scope received FDA 510(k) clearance on 2022-05-05, under approval number K211529.

What company makes NAVIRFA Scope?

NAVIRFA Scope is manufactured by Navifus Corporation.

What is the FDA product code for NAVIRFA Scope?

The FDA product code for NAVIRFA Scope is IYO.

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.

↑