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)

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B

K-Number: K851745 · 1985-08-29

ApplicantArtiberia
Decision Date1985-08-29
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B is the device name listed in this FDA 510(k) record. The listed applicant is Artiberia. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K851745. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B?

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Artiberia. The 510(k) number is K851745.

When did 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B receive FDA 510(k) clearance?

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B received FDA 510(k) clearance on 1985-08-29, under 510(k) number K851745.

Who is the listed applicant for 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B?

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

What is the FDA product code for 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B?

The FDA product code for 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B is ERA.

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 Artiberia 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.

K85178627-230 TO 27-234 VARIOUS CAST BREAKERS, WOLFK851718930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTESK8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAK8517191070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERSK8517231300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTSK8517201155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS

View all 79 devices →

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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.

↑