FDA 510(k)

PRO-SPEC

K-Number: K822084 · 1982-08-19

Decision Date1982-08-19

Product CodeHIB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PRO-SPEC is the device name listed in this FDA 510(k) record. The listed applicant is Exitec, Inc.. It received FDA 510(k) clearance on 1982-08-19 under 510(k) number K822084. 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 PRO-SPEC?

PRO-SPEC is a medical device that received FDA 510(k) clearance on 1982-08-19. The listed applicant is Exitec, Inc.. The 510(k) number is K822084.

When did PRO-SPEC receive FDA 510(k) clearance?

PRO-SPEC received FDA 510(k) clearance on 1982-08-19, under 510(k) number K822084.

Who is the listed applicant for PRO-SPEC?

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

What is the FDA product code for PRO-SPEC?

The FDA product code for PRO-SPEC is HIB.

Other records listing Exitec, 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.

K822085PRO-SCOPE K822087DIA SCOPE K822086DIA-SPEC

Related Devices (Code: HIB)

K252208JFord Speculum Sleeve™Ford Medtech, LLC K130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC K120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI Ltda K092870NON-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.