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FDA 510(k)

ERBOTOM ICC 300

K-Number: K953738 · 1995-10-16

ApplicantErbe Electromedizin GmbH
Decision Date1995-10-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBOTOM ICC 300 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 1995-10-16 under 510(k) number K953738. 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 ICC 300?

ERBOTOM ICC 300 is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Erbe Electromedizin GmbH. The 510(k) number is K953738.

When did ERBOTOM ICC 300 receive FDA 510(k) clearance?

ERBOTOM ICC 300 received FDA 510(k) clearance on 1995-10-16, under 510(k) number K953738.

Who is the listed applicant for ERBOTOM ICC 300?

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 ICC 300?

The FDA product code for ERBOTOM ICC 300 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.

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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.

K896055ERBOTOM ACC 450

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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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