Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JAZZ Solo sensor

K-Number: K213637 · 2021-12-10

ApplicantJazz Imaging, LLC Dba Jazz Imaging
Decision Date2021-12-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JAZZ Solo sensor is the device name listed in this FDA 510(k) record. The listed applicant is Jazz Imaging, LLC Dba Jazz Imaging. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K213637. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZZ Solo sensor?

JAZZ Solo sensor is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Jazz Imaging, LLC Dba Jazz Imaging. The 510(k) number is K213637.

When did JAZZ Solo sensor receive FDA 510(k) clearance?

JAZZ Solo sensor received FDA 510(k) clearance on 2021-12-10, under 510(k) number K213637.

Who is the listed applicant for JAZZ Solo sensor?

The FDA 510(k) record lists Jazz Imaging, LLC Dba Jazz Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ Solo sensor?

The FDA product code for JAZZ Solo sensor is MUH.

Related Devices (Code: MUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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.

↑