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FDA 510(k)

D6ZO DISPOSABLE HEAT EXCHANGER

K-Number: K813264 · 1982-07-06

ApplicantElectromedics, Inc.
Decision Date1982-07-06
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D6ZO DISPOSABLE HEAT EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1982-07-06 under 510(k) number K813264. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D6ZO DISPOSABLE HEAT EXCHANGER?

D6ZO DISPOSABLE HEAT EXCHANGER is a medical device that received FDA 510(k) clearance on 1982-07-06. The listed applicant is Electromedics, Inc.. The 510(k) number is K813264.

When did D6ZO DISPOSABLE HEAT EXCHANGER receive FDA 510(k) clearance?

D6ZO DISPOSABLE HEAT EXCHANGER received FDA 510(k) clearance on 1982-07-06, under 510(k) number K813264.

Who is the listed applicant for D6ZO DISPOSABLE HEAT EXCHANGER?

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 D6ZO DISPOSABLE HEAT EXCHANGER?

The FDA product code for D6ZO DISPOSABLE HEAT EXCHANGER is DTR.

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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: DTR)

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.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

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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