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)

SCAN WHITE 12 ML

K-Number: K955406 · 1995-12-28

ApplicantVident
Decision Date1995-12-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCAN WHITE 12 ML is the device name listed in this FDA 510(k) record. The listed applicant is Vident. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K955406. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCAN WHITE 12 ML?

SCAN WHITE 12 ML is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Vident. The 510(k) number is K955406.

When did SCAN WHITE 12 ML receive FDA 510(k) clearance?

SCAN WHITE 12 ML received FDA 510(k) clearance on 1995-12-28, under 510(k) number K955406.

Who is the listed applicant for SCAN WHITE 12 ML?

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

What is the FDA product code for SCAN WHITE 12 ML?

The FDA product code for SCAN WHITE 12 ML is ELW.

Related Clinical Trials

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.

Other records listing Vident 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.

View all 36 devices →

Related Devices (Code: ELW)

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.

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.

↑