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FDA 510(k)

PORTABLE AUTO TRANSFUSION SYSTEM 500

K-Number: K910238 · 1991-06-19

ApplicantElectromedics, Inc.
Decision Date1991-06-19
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE AUTO TRANSFUSION SYSTEM 500 is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1991-06-19 under 510(k) number K910238. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE AUTO TRANSFUSION SYSTEM 500?

PORTABLE AUTO TRANSFUSION SYSTEM 500 is a medical device that received FDA 510(k) clearance on 1991-06-19. The listed applicant is Electromedics, Inc.. The 510(k) number is K910238.

When did PORTABLE AUTO TRANSFUSION SYSTEM 500 receive FDA 510(k) clearance?

PORTABLE AUTO TRANSFUSION SYSTEM 500 received FDA 510(k) clearance on 1991-06-19, under 510(k) number K910238.

Who is the listed applicant for PORTABLE AUTO TRANSFUSION SYSTEM 500?

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 PORTABLE AUTO TRANSFUSION SYSTEM 500?

The FDA product code for PORTABLE AUTO TRANSFUSION SYSTEM 500 is CAC.

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Other records listing Electromedics, Inc. as applicant

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Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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