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FDA 510(k)

EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC

K-Number: K963377 · 1996-10-04

ApplicantNorth Eos Industries, Inc.
Decision Date1996-10-04
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC is the device name listed in this FDA 510(k) record. The listed applicant is North Eos Industries, Inc.. It received FDA 510(k) clearance on 1996-10-04 under 510(k) number K963377. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC?

EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC is a medical device that received FDA 510(k) clearance on 1996-10-04. The listed applicant is North Eos Industries, Inc.. The 510(k) number is K963377.

When did EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC receive FDA 510(k) clearance?

EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC received FDA 510(k) clearance on 1996-10-04, under 510(k) number K963377.

Who is the listed applicant for EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC?

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

What is the FDA product code for EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC?

The FDA product code for EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC is HIB.

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 North Eos Industries, 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.

K963685EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLERK954614EOS BRAND DISPOSABLE PROCTOSCOPE

Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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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