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FDA 510(k)

DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700

K-Number: K912188 · 1991-12-04

ApplicantCritikon Company, LLC
Decision Date1991-12-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 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 1991-12-04 under 510(k) number K912188. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700?

DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Critikon Company, LLC. The 510(k) number is K912188.

When did DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 receive FDA 510(k) clearance?

DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 received FDA 510(k) clearance on 1991-12-04, under 510(k) number K912188.

Who is the listed applicant for DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700?

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 DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700?

The FDA product code for DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 is MHX.

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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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