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FDA 510(k)

SIMPLEX AIRBRATOR

K-Number: K970249 · 1997-05-07

ApplicantSimplex Medical Systems, Inc.
Decision Date1997-05-07
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLEX AIRBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Simplex Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-05-07 under 510(k) number K970249. 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?

SIMPLEX AIRBRATOR is a medical device that received FDA 510(k) clearance on 1997-05-07. The listed applicant is Simplex Medical Systems, Inc.. The 510(k) number is K970249.

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

SIMPLEX AIRBRATOR received FDA 510(k) clearance on 1997-05-07, under 510(k) number K970249.

Who is the listed applicant for SIMPLEX AIRBRATOR?

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

What is the FDA product code for SIMPLEX AIRBRATOR?

The FDA product code for SIMPLEX AIRBRATOR 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 Simplex Medical Systems, 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.

K932288NEONATAL BREATHING CIRCUIT MODIFICATIONK904396SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM

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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