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FDA 510(k)

ACLAIMS-IS

K-Number: K912085 · 1991-10-31

ApplicantW-Technology
Decision Date1991-10-31
Product CodeLNJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACLAIMS-IS is the device name listed in this FDA 510(k) record. The listed applicant is W-Technology. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K912085. The device is classified under product code LNJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACLAIMS-IS?

ACLAIMS-IS is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is W-Technology. The 510(k) number is K912085.

When did ACLAIMS-IS receive FDA 510(k) clearance?

ACLAIMS-IS received FDA 510(k) clearance on 1991-10-31, under 510(k) number K912085.

Who is the listed applicant for ACLAIMS-IS?

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

What is the FDA product code for ACLAIMS-IS?

The FDA product code for ACLAIMS-IS is LNJ.

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Related Devices (Code: LNJ)

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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