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FDA 510(k)

ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20

K-Number: K902723 · 1990-12-13

ApplicantElectromedics, Inc.
Decision Date1990-12-13
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K902723. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20?

ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Electromedics, Inc.. The 510(k) number is K902723.

When did ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 receive FDA 510(k) clearance?

ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 received FDA 510(k) clearance on 1990-12-13, under 510(k) number K902723.

Who is the listed applicant for ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20?

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 ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20?

The FDA product code for ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 is DTM.

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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: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.

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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