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FDA 510(k)

SIM MODULE

K-Number: K874546 · 1988-05-11

ApplicantCritikon Company, LLC
Decision Date1988-05-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIM MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K874546. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIM MODULE?

SIM MODULE is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Critikon Company, LLC. The 510(k) number is K874546.

When did SIM MODULE receive FDA 510(k) clearance?

SIM MODULE received FDA 510(k) clearance on 1988-05-11, under 510(k) number K874546.

Who is the listed applicant for SIM MODULE?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIM MODULE?

The FDA product code for SIM MODULE is FRN.

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Other records listing Critikon Company, LLC as applicant

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

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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