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FDA 510(k)

RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM

K-Number: K963550 · 1996-11-01

ApplicantRespironics, Inc.
Decision Date1996-11-01
Product CodeKMA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1996-11-01 under 510(k) number K963550. The device is classified under product code KMA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM?

RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM is a medical device that received FDA 510(k) clearance on 1996-11-01. The listed applicant is Respironics, Inc.. The 510(k) number is K963550.

When did RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM receive FDA 510(k) clearance?

RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM received FDA 510(k) clearance on 1996-11-01, under 510(k) number K963550.

Who is the listed applicant for RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM?

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

What is the FDA product code for RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM?

The FDA product code for RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM is KMA.

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 Respironics, Inc. as applicant

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Related Devices (Code: KMA)

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.

K973875RINOFLOW MICRONIZED E.N.T. WASH SYSTEMRespironics, Inc.K950078MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.K822351POWDER BLOWERSKelleher Corp.

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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