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FDA 510(k)

APTEK ULTRASOUND PROCEDURE TRAY

K-Number: K802666 · 1980-11-26

ApplicantAptek , Ltd.
Decision Date1980-11-26
Product CodeHIO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

APTEK ULTRASOUND PROCEDURE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Aptek , Ltd.. It received FDA 510(k) clearance on 1980-11-26 under 510(k) number K802666. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTEK ULTRASOUND PROCEDURE TRAY?

APTEK ULTRASOUND PROCEDURE TRAY is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is Aptek , Ltd.. The 510(k) number is K802666.

When did APTEK ULTRASOUND PROCEDURE TRAY receive FDA 510(k) clearance?

APTEK ULTRASOUND PROCEDURE TRAY received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802666.

Who is the listed applicant for APTEK ULTRASOUND PROCEDURE TRAY?

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

What is the FDA product code for APTEK ULTRASOUND PROCEDURE TRAY?

The FDA product code for APTEK ULTRASOUND PROCEDURE TRAY is HIO.

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 Aptek , Ltd. 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.

K803157AUTO-MATE CAMERA

Related Devices (Code: HIO)

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.

K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical SystemsK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.K914419AMNIOTEST(TM)Pro-Lab, Inc.K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.

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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