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FDA 510(k)

CRITIKON CENTRAL STATIN MONITOR

K-Number: K933404 · 1994-02-09

ApplicantCritikon Company, LLC
Decision Date1994-02-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKON CENTRAL STATIN MONITOR 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 1994-02-09 under 510(k) number K933404. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIKON CENTRAL STATIN MONITOR?

CRITIKON CENTRAL STATIN MONITOR is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Critikon Company, LLC. The 510(k) number is K933404.

When did CRITIKON CENTRAL STATIN MONITOR receive FDA 510(k) clearance?

CRITIKON CENTRAL STATIN MONITOR received FDA 510(k) clearance on 1994-02-09, under 510(k) number K933404.

Who is the listed applicant for CRITIKON CENTRAL STATIN MONITOR?

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 CRITIKON CENTRAL STATIN MONITOR?

The FDA product code for CRITIKON CENTRAL STATIN MONITOR is DPS.

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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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Related Devices (Code: DPS)

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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