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FDA 510(k)

DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT

K-Number: K971742 · 1997-07-24

ApplicantDepuy, Inc.
Decision Date1997-07-24
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K971742. 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 DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT?

DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Depuy, Inc.. The 510(k) number is K971742.

When did DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT receive FDA 510(k) clearance?

DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971742.

Who is the listed applicant for DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT?

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

What is the FDA product code for DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT?

The FDA product code for DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT is FMQ.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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

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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