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FDA 510(k)

CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)

K-Number: K963453 · 1996-11-15

ApplicantContour Fabricators, Inc.
Decision Date1996-11-15
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) is the device name listed in this FDA 510(k) record. The listed applicant is Contour Fabricators, Inc.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K963453. 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 CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)?

CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Contour Fabricators, Inc.. The 510(k) number is K963453.

When did CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) receive FDA 510(k) clearance?

CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) received FDA 510(k) clearance on 1996-11-15, under 510(k) number K963453.

Who is the listed applicant for CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)?

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

What is the FDA product code for CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)?

The FDA product code for CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) 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.

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Other records listing Contour Fabricators, 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.

K090773CFI ULTRASOUND PROBE DRAPEK970900INSTRUMENT HOLDERK971040CABLE HOLDER, SUCTION TUBE HOLDERK970185STERILE DISPOSABLE EQUIPMENT MAGNET COVERK964141GE STERILE DISPOSABLE EQUIPMENT COIL COVERK820692BANDBAG, WRAP, STERILE

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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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