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)

CENTRALITE(R)-DLL SERIES

K-Number: K950112 · 1995-08-16

ApplicantDiacor, Inc.
Decision Date1995-08-16
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CENTRALITE(R)-DLL SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Diacor, Inc.. It received FDA 510(k) clearance on 1995-08-16 under 510(k) number K950112. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRALITE(R)-DLL SERIES?

CENTRALITE(R)-DLL SERIES is a medical device that received FDA 510(k) clearance on 1995-08-16. The listed applicant is Diacor, Inc.. The 510(k) number is K950112.

When did CENTRALITE(R)-DLL SERIES receive FDA 510(k) clearance?

CENTRALITE(R)-DLL SERIES received FDA 510(k) clearance on 1995-08-16, under 510(k) number K950112.

Who is the listed applicant for CENTRALITE(R)-DLL SERIES?

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

What is the FDA product code for CENTRALITE(R)-DLL SERIES?

The FDA product code for CENTRALITE(R)-DLL SERIES is IWE.

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

Other records listing Diacor, Inc. 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.

K121929ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDK050888INTEGRA IMMOBILIZATION SYSTEMK954414CENTRALITE BACKPOINTERK953046PERI-PUSHERK934566RADASSISTK930246MAMMORX

View all 10 devices →

Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, Inc.K943802HP BACK POINTER SYSTEMMedtec, 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.

↑