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)

C015

K-Number: K192182 · 2020-01-17

ApplicantMicronica Srl
Decision Date2020-01-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C015 is a medical device manufactured by Micronica Srl. It received FDA 510(k) clearance on 2020-01-17 under approval number K192182. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C015?

C015 is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Micronica Srl. The 510(k) number is K192182.

When was C015 approved by the FDA?

C015 received FDA 510(k) clearance on 2020-01-17, under approval number K192182.

What company makes C015?

C015 is manufactured by Micronica Srl.

What is the FDA product code for C015?

The FDA product code for C015 is OWB.

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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.

↑