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FDA 510(k)

NASAL INSTRUMENTS

K-Number: K820621 · 1982-03-19

ApplicantApplied Fiberoptics, Inc.
Decision Date1982-03-19
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Applied Fiberoptics, Inc.. It received FDA 510(k) clearance on 1982-03-19 under 510(k) number K820621. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASAL INSTRUMENTS?

NASAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1982-03-19. The listed applicant is Applied Fiberoptics, Inc.. The 510(k) number is K820621.

When did NASAL INSTRUMENTS receive FDA 510(k) clearance?

NASAL INSTRUMENTS received FDA 510(k) clearance on 1982-03-19, under 510(k) number K820621.

Who is the listed applicant for NASAL INSTRUMENTS?

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

What is the FDA product code for NASAL INSTRUMENTS?

The FDA product code for NASAL INSTRUMENTS is EQH.

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 Applied Fiberoptics, 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.

K964037FLEXIBLE CYSTOSCOPEK964482FLEXIBLE URETEROSCOPE

Related Devices (Code: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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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