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)

VIDEO OTOSCOPE

K-Number: K943731 · 1994-10-11

ApplicantCuda Products Co.
Decision Date1994-10-11
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VIDEO OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Cuda Products Co.. It received FDA 510(k) clearance on 1994-10-11 under 510(k) number K943731. 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 VIDEO OTOSCOPE?

VIDEO OTOSCOPE is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Cuda Products Co.. The 510(k) number is K943731.

When did VIDEO OTOSCOPE receive FDA 510(k) clearance?

VIDEO OTOSCOPE received FDA 510(k) clearance on 1994-10-11, under 510(k) number K943731.

Who is the listed applicant for VIDEO OTOSCOPE?

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

What is the FDA product code for VIDEO OTOSCOPE?

The FDA product code for VIDEO OTOSCOPE 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 Cuda Products 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.

K983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCEK981469CERMAX300 LIGHTSOURCEK980350VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150K980166LIGHTSOURCE OR ILLUMINATORK961074LIGHTSOURCE OR ILLUMINATOR

View all 17 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.

↑