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FDA 510(k)

ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

K-Number: K121775 · 2012-11-28

ApplicantVital Signs, Inc., A GE Healthcare Company
Decision Date2012-11-28
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER 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 2012-11-28 under 510(k) number K121775. 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, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER?

ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER is a medical device that received FDA 510(k) clearance on 2012-11-28. The listed applicant is Vital Signs, Inc., A GE Healthcare Company. The 510(k) number is K121775.

When did ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER receive FDA 510(k) clearance?

ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER received FDA 510(k) clearance on 2012-11-28, under 510(k) number K121775.

Who is the listed applicant for ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER?

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, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER?

The FDA product code for ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER is LGZ.

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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.

K130867ENFLOW IV FLUID WARMER INSULATED STRAP

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

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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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