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FDA 510(k)

HEELBO ICU 911 BLAZER SLEEVED JACKET

K-Number: K963237 · 1996-10-09

ApplicantHeelbo, Inc.
Decision Date1996-10-09
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEELBO ICU 911 BLAZER SLEEVED JACKET is the device name listed in this FDA 510(k) record. The listed applicant is Heelbo, Inc.. It received FDA 510(k) clearance on 1996-10-09 under 510(k) number K963237. 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 HEELBO ICU 911 BLAZER SLEEVED JACKET?

HEELBO ICU 911 BLAZER SLEEVED JACKET is a medical device that received FDA 510(k) clearance on 1996-10-09. The listed applicant is Heelbo, Inc.. The 510(k) number is K963237.

When did HEELBO ICU 911 BLAZER SLEEVED JACKET receive FDA 510(k) clearance?

HEELBO ICU 911 BLAZER SLEEVED JACKET received FDA 510(k) clearance on 1996-10-09, under 510(k) number K963237.

Who is the listed applicant for HEELBO ICU 911 BLAZER SLEEVED JACKET?

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

What is the FDA product code for HEELBO ICU 911 BLAZER SLEEVED JACKET?

The FDA product code for HEELBO ICU 911 BLAZER SLEEVED JACKET is FMQ.

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Other records listing Heelbo, 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.

K980640HEELBO WAIST AND CHEST VESTK963372HEELBO ER WRIST RESTRAINTK963060HEELBO SECURITY BELTK963099HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKETK963041HEELBO LIFE JACKET WITH CROTCH SUPPORTK962834HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP

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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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