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FDA 510(k)

ERBOTOM ICC 200

K-Number: K933157 · 1994-02-23

ApplicantErbe USA, Inc.
Decision Date1994-02-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBOTOM ICC 200 is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 1994-02-23 under 510(k) number K933157. 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 200?

ERBOTOM ICC 200 is a medical device that received FDA 510(k) clearance on 1994-02-23. The listed applicant is Erbe USA, Inc.. The 510(k) number is K933157.

When did ERBOTOM ICC 200 receive FDA 510(k) clearance?

ERBOTOM ICC 200 received FDA 510(k) clearance on 1994-02-23, under 510(k) number K933157.

Who is the listed applicant for ERBOTOM ICC 200?

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

What is the FDA product code for ERBOTOM ICC 200?

The FDA product code for ERBOTOM ICC 200 is GEI.

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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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