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)

Second Opinion

K-Number: K210365 · 2022-03-04

ApplicantPearl, Inc.
Decision Date2022-03-04
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Second Opinion is a medical device manufactured by Pearl, Inc.. It received FDA 510(k) clearance on 2022-03-04 under approval number K210365. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Second Opinion?

Second Opinion is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Pearl, Inc.. The 510(k) number is K210365.

When was Second Opinion approved by the FDA?

Second Opinion received FDA 510(k) clearance on 2022-03-04, under approval number K210365.

What company makes Second Opinion?

Second Opinion is manufactured by Pearl, Inc..

What is the FDA product code for Second Opinion?

The FDA product code for Second Opinion is MYN.

Related Clinical Trials

NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07071935 A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS) NOT_YET_RECRUITING

Other Devices by Pearl, Inc.

K250525Second Opinion® Panoramic K243234Second Opinion® CS K243989Second Opinion® 3D K243230Second Opinion® BLE K243893Second Opinion® Pediatric K242600Second Opinion Periapical Radiolucency Contours

View all 8 devices →

Related Devices (Code: MYN)

K201560Auto Lung Nodule DetectionSamsung Electronics Co., Ltd. K210666Chest-CADImagen Technologies, Inc. K220928Overjet Calculus AssistOverjet, Inc. K213353Aorta-CADImagen Technologies, Inc. K212519Overjet Caries AssistOverjet, Inc. K213795Videa Caries AssistVideahealth, 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.

↑