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FDA 510(k)

HOSPITAL'S SPEC

K-Number: K974228 · 1997-12-12

ApplicantGps
Decision Date1997-12-12
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HOSPITAL'S SPEC is the device name listed in this FDA 510(k) record. The listed applicant is Gps. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K974228. 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 HOSPITAL'S SPEC?

HOSPITAL'S SPEC is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Gps. The 510(k) number is K974228.

When did HOSPITAL'S SPEC receive FDA 510(k) clearance?

HOSPITAL'S SPEC received FDA 510(k) clearance on 1997-12-12, under 510(k) number K974228.

Who is the listed applicant for HOSPITAL'S SPEC?

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

What is the FDA product code for HOSPITAL'S SPEC?

The FDA product code for HOSPITAL'S SPEC 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 Gps 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.

K974227HOSPITAL'S CLAMP

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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