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FDA 510(k)

ERBOTOM ACC 450

K-Number: K896055 · 1990-02-13

ApplicantErbe Electromedizin GmbH
Decision Date1990-02-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBOTOM ACC 450 is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Electromedizin GmbH. It received FDA 510(k) clearance on 1990-02-13 under 510(k) number K896055. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERBOTOM ACC 450?

ERBOTOM ACC 450 is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is Erbe Electromedizin GmbH. The 510(k) number is K896055.

When did ERBOTOM ACC 450 receive FDA 510(k) clearance?

ERBOTOM ACC 450 received FDA 510(k) clearance on 1990-02-13, under 510(k) number K896055.

Who is the listed applicant for ERBOTOM ACC 450?

The FDA 510(k) record lists Erbe Electromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERBOTOM ACC 450?

The FDA product code for ERBOTOM ACC 450 is GEI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Erbe Electromedizin GmbH 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.

K953738ERBOTOM ICC 300

Related Devices (Code: GEI)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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