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FDA 510(k)

PALCERAM 49

K-Number: K001481 · 2000-06-23

ApplicantAurex SA (Pty) , Ltd.
Decision Date2000-06-23
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALCERAM 49 is the device name listed in this FDA 510(k) record. The listed applicant is Aurex SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K001481. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALCERAM 49?

PALCERAM 49 is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Aurex SA (Pty) , Ltd.. The 510(k) number is K001481.

When did PALCERAM 49 receive FDA 510(k) clearance?

PALCERAM 49 received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001481.

Who is the listed applicant for PALCERAM 49?

The FDA 510(k) record lists Aurex SA (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALCERAM 49?

The FDA product code for PALCERAM 49 is EJT.

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 Aurex SA (Pty) , Ltd. 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.

K001482AURENORM 75 KFK001480AURECAST 40 BK001479PALCERAM 53K001477AURELUX Y 84 PREMIUMK001478AURECAST SUPER INLAY

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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