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)

Spot Skan

K-Number: K152831 · 2016-02-23

ApplicantSkanray Technologies Private Limited
Decision Date2016-02-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spot Skan is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Private Limited. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K152831. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spot Skan?

Spot Skan is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Skanray Technologies Private Limited. The 510(k) number is K152831.

When did Spot Skan receive FDA 510(k) clearance?

Spot Skan received FDA 510(k) clearance on 2016-02-23, under 510(k) number K152831.

Who is the listed applicant for Spot Skan?

The FDA 510(k) record lists Skanray Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spot Skan?

The FDA product code for Spot Skan is DXN.

Other records listing Skanray Technologies Private Limited as applicant

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.

K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantK170967Intraskan DC PlusK151512Star 60

Related Devices (Code: DXN)

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.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

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.

↑