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FDA 510(k)

GUAMSTAINER

K-Number: K811697 · 1981-07-02

ApplicantTomtec
Decision Date1981-07-02
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

GUAMSTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811697. The device is classified under product code KPA. It was reviewed by the PA advisory panel. Product code KPA falls under the category of Cardiovascular, which encompasses devices for cardiovascular diagnosis, monitoring, and intervention. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUAMSTAINER?

GUAMSTAINER is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Tomtec. The 510(k) number is K811697.

When did GUAMSTAINER receive FDA 510(k) clearance?

GUAMSTAINER received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811697.

Who is the listed applicant for GUAMSTAINER?

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

What is the FDA product code for GUAMSTAINER?

The FDA product code for GUAMSTAINER is KPA. This falls under the Cardiovascular category.

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 Tomtec 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.

K771569AUTOSTREAKER

Related Devices (Code: KPA)

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.

K933996PROFIBLOTTecan U.S., Ltd.K884258VERSABLOTAmerican Bionetics, Inc.K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., Inc.

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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