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FDA 510(k)

ALLEN, ULTRA AND SMART SOCKETS

K-Number: K971988 · 1997-07-11

ApplicantAllen Medical Systems, Inc.
Decision Date1997-07-11
Product CodeFQO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLEN, ULTRA AND SMART SOCKETS is the device name listed in this FDA 510(k) record. The listed applicant is Allen Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-07-11 under 510(k) number K971988. The device is classified under product code FQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEN, ULTRA AND SMART SOCKETS?

ALLEN, ULTRA AND SMART SOCKETS is a medical device that received FDA 510(k) clearance on 1997-07-11. The listed applicant is Allen Medical Systems, Inc.. The 510(k) number is K971988.

When did ALLEN, ULTRA AND SMART SOCKETS receive FDA 510(k) clearance?

ALLEN, ULTRA AND SMART SOCKETS received FDA 510(k) clearance on 1997-07-11, under 510(k) number K971988.

Who is the listed applicant for ALLEN, ULTRA AND SMART SOCKETS?

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

What is the FDA product code for ALLEN, ULTRA AND SMART SOCKETS?

The FDA product code for ALLEN, ULTRA AND SMART SOCKETS is FQO.

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 Allen Medical Systems, 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.

K964273DURA-BOARD ARMBOARDK960027HIGH VOLUME I.V. & IRRIGATION TOWERK944779CARBON LIGHTS HAND SURGERY TABLEK921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000

Related Devices (Code: FQO)

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.

K240598Maestro System (REF100)Moon SurgicalK221410Maestro PlatformMoon SurgicalK090136STERIS CMAX XLT SURGICAL TABLESTERIS CorporationK972810OPT80 THE TRANSPORTABLE (OPT80)O.P.T. USA, Inc.K971307AMSCO SURGICAL TABLESTERIS CorporationK963506TENET RADIOLUCENT HAND TABLETenet Medical Engineering

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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