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FDA 510(k)

MEDISON 4800

K-Number: K925582 · 1994-12-27

ApplicantMedison America, Inc.
Decision Date1994-12-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDISON 4800 is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K925582. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISON 4800?

MEDISON 4800 is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Medison America, Inc.. The 510(k) number is K925582.

When did MEDISON 4800 receive FDA 510(k) clearance?

MEDISON 4800 received FDA 510(k) clearance on 1994-12-27, under 510(k) number K925582.

Who is the listed applicant for MEDISON 4800?

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

What is the FDA product code for MEDISON 4800?

The FDA product code for MEDISON 4800 is IYO.

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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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