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FDA 510(k)

ENFLOW IV FLUID WARMER INSULATED STRAP

K-Number: K130867 · 2013-06-14

ApplicantVital Signs, Inc., A GE Healthcare Company
Decision Date2013-06-14
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENFLOW IV FLUID WARMER INSULATED STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc., A GE Healthcare Company. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K130867. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENFLOW IV FLUID WARMER INSULATED STRAP?

ENFLOW IV FLUID WARMER INSULATED STRAP is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Vital Signs, Inc., A GE Healthcare Company. The 510(k) number is K130867.

When did ENFLOW IV FLUID WARMER INSULATED STRAP receive FDA 510(k) clearance?

ENFLOW IV FLUID WARMER INSULATED STRAP received FDA 510(k) clearance on 2013-06-14, under 510(k) number K130867.

Who is the listed applicant for ENFLOW IV FLUID WARMER INSULATED STRAP?

The FDA 510(k) record lists Vital Signs, Inc., A GE Healthcare Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFLOW IV FLUID WARMER INSULATED STRAP?

The FDA product code for ENFLOW IV FLUID WARMER INSULATED STRAP is LGZ.

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 Vital Signs, Inc., A GE Healthcare Company 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.

K121775ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

Related Devices (Code: LGZ)

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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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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