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FDA 510(k)

ENTERAL NUTRITION WARMER

K-Number: K122449 · 2013-06-13

ApplicantAcacia, Inc.
Decision Date2013-06-13
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTERAL NUTRITION WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Acacia, Inc.. It received FDA 510(k) clearance on 2013-06-13 under 510(k) number K122449. 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 ENTERAL NUTRITION WARMER?

ENTERAL NUTRITION WARMER is a medical device that received FDA 510(k) clearance on 2013-06-13. The listed applicant is Acacia, Inc.. The 510(k) number is K122449.

When did ENTERAL NUTRITION WARMER receive FDA 510(k) clearance?

ENTERAL NUTRITION WARMER received FDA 510(k) clearance on 2013-06-13, under 510(k) number K122449.

Who is the listed applicant for ENTERAL NUTRITION WARMER?

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

What is the FDA product code for ENTERAL NUTRITION WARMER?

The FDA product code for ENTERAL NUTRITION WARMER is LGZ.

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Other records listing Acacia, 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.

K111381MEDI-SIS SYRINGE INFUSION SYSTEMK103165BLOOD SAMPLING SETK092986ACACIA PISTON SYRINGEK972538FLOW-EZE BLUNT CANNULA (1999BC)K931095SPRING LOADED SYRINGEK912771ACACIAS PHARM/PUMP

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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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