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FDA 510(k)

CRITIKON VITAL SIGNS MODULE

K-Number: K915697 · 1993-07-01

ApplicantCritikon Company, LLC
Decision Date1993-07-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKON VITAL SIGNS 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 1993-07-01 under 510(k) number K915697. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIKON VITAL SIGNS MODULE?

CRITIKON VITAL SIGNS MODULE is a medical device that received FDA 510(k) clearance on 1993-07-01. The listed applicant is Critikon Company, LLC. The 510(k) number is K915697.

When did CRITIKON VITAL SIGNS MODULE receive FDA 510(k) clearance?

CRITIKON VITAL SIGNS MODULE received FDA 510(k) clearance on 1993-07-01, under 510(k) number K915697.

Who is the listed applicant for CRITIKON VITAL SIGNS 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 CRITIKON VITAL SIGNS MODULE?

The FDA product code for CRITIKON VITAL SIGNS MODULE is DXN.

Related Clinical Trials

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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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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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Related Devices (Code: DXN)

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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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