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)

REFLECTIONS

K-Number: K934881 · 1994-02-01

ApplicantCdb Corp.
Decision Date1994-02-01
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REFLECTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corp.. It received FDA 510(k) clearance on 1994-02-01 under 510(k) number K934881. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLECTIONS?

REFLECTIONS is a medical device that received FDA 510(k) clearance on 1994-02-01. The listed applicant is Cdb Corp.. The 510(k) number is K934881.

When did REFLECTIONS receive FDA 510(k) clearance?

REFLECTIONS received FDA 510(k) clearance on 1994-02-01, under 510(k) number K934881.

Who is the listed applicant for REFLECTIONS?

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

What is the FDA product code for REFLECTIONS?

The FDA product code for REFLECTIONS is EJF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related PubMed Literature

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.

PMID: 38600418Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.Therapeutic innovation & regulatory science ()PMID: 34243826Measuring Patient Preferences at the FDA Center for Devices and Radiological Health: Reflections and Projections.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research ()

Other records listing Cdb Corp. 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.

K973776REFLECTIONSK922499REFLECTIONS - CERAMIC DENTAL BRACKET

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, 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.

↑