Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

K-Number: K830090 · 1983-02-07

ApplicantHudson Oxygen Therapy Sales Co.
Decision Date1983-02-07
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Oxygen Therapy Sales Co.. It received FDA 510(k) clearance on 1983-02-07 under 510(k) number K830090. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR?

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Hudson Oxygen Therapy Sales Co.. The 510(k) number is K830090.

When did DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR receive FDA 510(k) clearance?

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR received FDA 510(k) clearance on 1983-02-07, under 510(k) number K830090.

Who is the listed applicant for DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR?

The FDA 510(k) record lists Hudson Oxygen Therapy Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR?

The FDA product code for DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR is JXL.

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 Hudson Oxygen Therapy Sales Co. 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.

K902062PEEP VALVEK900783MDI ADAPTORK900470IN-THE NEBULIZERK895589MANUAL RESUSCITATORK896136INFANT C.P.A.P. MONITORK895231CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER

View all 33 devices →

Related Devices (Code: JXL)

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.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, 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.

↑