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FDA 510(k)

HEAD HOLDING DEVICE/SLEEP APNEA

K-Number: K884493 · 1989-01-12

ApplicantX-Ray Systems
Decision Date1989-01-12
Product CodeIWY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEAD HOLDING DEVICE/SLEEP APNEA is the device name listed in this FDA 510(k) record. The listed applicant is X-Ray Systems. It received FDA 510(k) clearance on 1989-01-12 under 510(k) number K884493. The device is classified under product code IWY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAD HOLDING DEVICE/SLEEP APNEA?

HEAD HOLDING DEVICE/SLEEP APNEA is a medical device that received FDA 510(k) clearance on 1989-01-12. The listed applicant is X-Ray Systems. The 510(k) number is K884493.

When did HEAD HOLDING DEVICE/SLEEP APNEA receive FDA 510(k) clearance?

HEAD HOLDING DEVICE/SLEEP APNEA received FDA 510(k) clearance on 1989-01-12, under 510(k) number K884493.

Who is the listed applicant for HEAD HOLDING DEVICE/SLEEP APNEA?

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

What is the FDA product code for HEAD HOLDING DEVICE/SLEEP APNEA?

The FDA product code for HEAD HOLDING DEVICE/SLEEP APNEA is IWY.

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 X-Ray Systems 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.

K855161UPRIGHT BUCKY STAND/MOUNTK855052TABLE RADIOGRAPHIC FIXEDK853682MOUNT TUBE RADIOGRAPHIC

Related Devices (Code: IWY)

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.

K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.K884847MTD HEDRESTComposites Horizons, Inc.K864527DUOCEPHGary E. Hall, DdsK850197KELLER CEPHALOMETRIC DEVICEGary D. KellerK844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.K843340PORTA-STATPorta-Stat, 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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