EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC— 510(k) K963377

Name: FDA 510(k) clearance K963377
Creator: U.S. Food and Drug Administration
Published: 1996-10-04

Substantially Equivalent

North Eos Industries, Inc.

FDA 510(k) clearance K963377 for EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC, Substantially Equivalent on 1996-10-04. Applicant: North Eos Industries, Inc.. Device class: 2.

Clearance details

Applicant: North Eos Industries, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1996-08-27
Decision date: 1996-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung Hsien, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIB

view all

K252208 — JFord Speculum Sleeve2026-03-06
K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM2014-04-28
K132668 — IOB DISPOSABLE SPECULUM2014-01-17
K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM2013-08-06
K120743 — SPECULUM, VAGINAL, NONMETAL2012-03-23

More clearances from North Eos Industries, Inc.

view all

K963685 — EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER1996-10-11
K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE1996-04-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.