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FDA 510(k)

UNITRON MODEL IKON AOHPL

K-Number: K953646 · 1995-08-28

ApplicantUnitron Industries, Inc.
Decision Date1995-08-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNITRON MODEL IKON AOHPL is the device name listed in this FDA 510(k) record. The listed applicant is Unitron Industries, Inc.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K953646. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITRON MODEL IKON AOHPL?

UNITRON MODEL IKON AOHPL is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Unitron Industries, Inc.. The 510(k) number is K953646.

When did UNITRON MODEL IKON AOHPL receive FDA 510(k) clearance?

UNITRON MODEL IKON AOHPL received FDA 510(k) clearance on 1995-08-28, under 510(k) number K953646.

Who is the listed applicant for UNITRON MODEL IKON AOHPL?

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

What is the FDA product code for UNITRON MODEL IKON AOHPL?

The FDA product code for UNITRON MODEL IKON AOHPL is ESD.

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Other records listing Unitron Industries, Inc. as applicant

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Related Devices (Code: ESD)

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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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