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)

PHYSIOSTAR NFC

K-Number: K122852 · 2012-12-06

ApplicantCandulor USA, Inc.
Decision Date2012-12-06
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHYSIOSTAR NFC is the device name listed in this FDA 510(k) record. The listed applicant is Candulor USA, Inc.. It received FDA 510(k) clearance on 2012-12-06 under 510(k) number K122852. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIOSTAR NFC?

PHYSIOSTAR NFC is a medical device that received FDA 510(k) clearance on 2012-12-06. The listed applicant is Candulor USA, Inc.. The 510(k) number is K122852.

When did PHYSIOSTAR NFC receive FDA 510(k) clearance?

PHYSIOSTAR NFC received FDA 510(k) clearance on 2012-12-06, under 510(k) number K122852.

Who is the listed applicant for PHYSIOSTAR NFC?

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

What is the FDA product code for PHYSIOSTAR NFC?

The FDA product code for PHYSIOSTAR NFC is ELM.

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 Candulor USA, 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.

K101814DIRECT CROWN NATURAL 1

Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AGK113426VERACIA SAShofu Dental Corporation

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.

↑