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FDA 510(k)

SIMPLEX AIRBRATOR (SAB-7)

K-Number: K980672 · 2000-05-04

ApplicantIrt Management Corp.
Decision Date2000-05-04
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLEX AIRBRATOR (SAB-7) is the device name listed in this FDA 510(k) record. The listed applicant is Irt Management Corp.. It received FDA 510(k) clearance on 2000-05-04 under 510(k) number K980672. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLEX AIRBRATOR (SAB-7)?

SIMPLEX AIRBRATOR (SAB-7) is a medical device that received FDA 510(k) clearance on 2000-05-04. The listed applicant is Irt Management Corp.. The 510(k) number is K980672.

When did SIMPLEX AIRBRATOR (SAB-7) receive FDA 510(k) clearance?

SIMPLEX AIRBRATOR (SAB-7) received FDA 510(k) clearance on 2000-05-04, under 510(k) number K980672.

Who is the listed applicant for SIMPLEX AIRBRATOR (SAB-7)?

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

What is the FDA product code for SIMPLEX AIRBRATOR (SAB-7)?

The FDA product code for SIMPLEX AIRBRATOR (SAB-7) is KOJ.

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 Irt Management 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.

K980783SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5

Related Devices (Code: KOJ)

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, 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.

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