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FDA 510(k)

ISOLA ANTERIOR SYSTEM

K-Number: K943819 · 1995-02-09

ApplicantAcromed Corp.
Decision Date1995-02-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ISOLA ANTERIOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K943819. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ISOLA ANTERIOR SYSTEM?

ISOLA ANTERIOR SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Acromed Corp.. The 510(k) number is K943819.

When did ISOLA ANTERIOR SYSTEM receive FDA 510(k) clearance?

ISOLA ANTERIOR SYSTEM received FDA 510(k) clearance on 1995-02-09, under 510(k) number K943819.

Who is the listed applicant for ISOLA ANTERIOR SYSTEM?

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

What is the FDA product code for ISOLA ANTERIOR SYSTEM?

The FDA product code for ISOLA ANTERIOR SYSTEM is KWQ.

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Other records listing Acromed Corp. as applicant

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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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