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FDA 510(k)

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM

K-Number: K072762 · 2008-01-22

ApplicantDepalt, Inc.
Decision Date2008-01-22
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depalt, Inc.. It received FDA 510(k) clearance on 2008-01-22 under 510(k) number K072762. 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 DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM?

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-22. The listed applicant is Depalt, Inc.. The 510(k) number is K072762.

When did DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM receive FDA 510(k) clearance?

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM received FDA 510(k) clearance on 2008-01-22, under 510(k) number K072762.

Who is the listed applicant for DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM?

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

What is the FDA product code for DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM?

The FDA product code for DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM is HIB.

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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