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)

ARDENT NON GAMMA-2 70

K-Number: K964192 · 1997-01-06

ApplicantArdent Production Development
Decision Date1997-01-06
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARDENT NON GAMMA-2 70 is the device name listed in this FDA 510(k) record. The listed applicant is Ardent Production Development. It received FDA 510(k) clearance on 1997-01-06 under 510(k) number K964192. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARDENT NON GAMMA-2 70?

ARDENT NON GAMMA-2 70 is a medical device that received FDA 510(k) clearance on 1997-01-06. The listed applicant is Ardent Production Development. The 510(k) number is K964192.

When did ARDENT NON GAMMA-2 70 receive FDA 510(k) clearance?

ARDENT NON GAMMA-2 70 received FDA 510(k) clearance on 1997-01-06, under 510(k) number K964192.

Who is the listed applicant for ARDENT NON GAMMA-2 70?

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

What is the FDA product code for ARDENT NON GAMMA-2 70?

The FDA product code for ARDENT NON GAMMA-2 70 is EJJ.

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 Ardent Production Development 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.

K964775ARDENT FUTURA NON GAMMA-2

Related Devices (Code: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

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.

↑