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FDA 510(k)

BT 794-BLOOD/FLUID WARMER

K-Number: K822098 · 1982-08-20

ApplicantElectromedics, Inc.
Decision Date1982-08-20
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BT 794-BLOOD/FLUID WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1982-08-20 under 510(k) number K822098. 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 BT 794-BLOOD/FLUID WARMER?

BT 794-BLOOD/FLUID WARMER is a medical device that received FDA 510(k) clearance on 1982-08-20. The listed applicant is Electromedics, Inc.. The 510(k) number is K822098.

When did BT 794-BLOOD/FLUID WARMER receive FDA 510(k) clearance?

BT 794-BLOOD/FLUID WARMER received FDA 510(k) clearance on 1982-08-20, under 510(k) number K822098.

Who is the listed applicant for BT 794-BLOOD/FLUID WARMER?

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

What is the FDA product code for BT 794-BLOOD/FLUID WARMER?

The FDA product code for BT 794-BLOOD/FLUID WARMER is LGZ.

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Other records listing Electromedics, 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.

K934964ELECTROMEDICS TYMPANIC TEMPERATURE SENSORK933832ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSORK934355ELECTROMEDICS BLOOD HEAT EXCHANGERK930154EL2-SERIES BLOOD COLLECTION REERVOIRK926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRK925412ELECTROMEDICS TISSUE TRAP/ #TT280

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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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