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FDA 510(k)

INTREX

K-Number: K833241 · 1983-10-28

ApplicantPennwalt Corp.
Decision Date1983-10-28
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTREX is the device name listed in this FDA 510(k) record. The listed applicant is Pennwalt Corp.. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K833241. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTREX?

INTREX is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Pennwalt Corp.. The 510(k) number is K833241.

When did INTREX receive FDA 510(k) clearance?

INTREX received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833241.

Who is the listed applicant for INTREX?

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

What is the FDA product code for INTREX?

The FDA product code for INTREX is EAP.

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 Pennwalt 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.

K801860S.S. WHITE-PENNWALT RENEW CALCIUM HYDROXK801274S.S. WHITE-PENNWALT PRELUDE PIT SEALANTK800133PANOREX II DENTAL X-RAY UNITK800063XR-710K780981PORTABLE PNEUMATIC CALIBRATOR 65-150

Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.

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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