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FDA 510(k)

PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905

K-Number: K972123 · 1997-07-25

ApplicantSmith
Decision Date1997-07-25
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 is the device name listed in this FDA 510(k) record. The listed applicant is Smith. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K972123. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905?

PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Smith. The 510(k) number is K972123.

When did PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 receive FDA 510(k) clearance?

PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 received FDA 510(k) clearance on 1997-07-25, under 510(k) number K972123.

Who is the listed applicant for PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905?

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

What is the FDA product code for PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905?

The FDA product code for PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 is FMQ.

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 Smith 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.

K973747CONTROLLED TEMPERATURE CABINET SYSTEMK973748TEMPO AND TEMP H20K971092QA-ESK970555IL0292 DP ECHOPORT

Related Devices (Code: FMQ)

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.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

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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