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Dinamap Plus Physiological Monitor Model 8700

by Critikon Company, LLC

510(k) K912188

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912188 Date4 Dec 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dinamap Plus Physiological Monitor Model 8700 is a physiological patient monitor with arrhythmia detection or alarms, classified under the cardiovascular medical specialty. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device was cleared under regulation number 870.1025 with product code MHX and traditional clearance type. It was manufactured by Critikon Company, LLC in Tampa, Florida, and received FDA clearance on December 4, 1991, following submission on May 17, 1991.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Dinamap Plus Physiological Monitor Model 8700 used for?

    The Dinamap Plus Physiological Monitor Model 8700 is a physiological patient monitor designed to detect arrhythmias and provide alarms, used in cardiovascular care settings to monitor patient vital signs.

  • Who manufactures the Dinamap Plus Physiological Monitor Model 8700 and where is it made?

    The Dinamap Plus Physiological Monitor Model 8700 is manufactured by Critikon Company, LLC in Tampa, Florida, United States.

  • When did the Dinamap Plus Physiological Monitor Model 8700 receive FDA clearance?

    The Dinamap Plus Physiological Monitor Model 8700 received FDA 510(k) clearance on December 4, 1991, following submission on May 17, 1991.

  • What regulatory classification and product code apply to the Dinamap Plus Physiological Monitor Model 8700?

    The Dinamap Plus Physiological Monitor Model 8700 is classified as a Class II medical device under regulation number 870.1025 with product code MHX.

  • Is the Dinamap Plus Physiological Monitor Model 8700 substantially equivalent to a predicate device?

    Yes, the Dinamap Plus Physiological Monitor Model 8700 was cleared as substantially equivalent to a predicate device under the FDA's traditional 510(k) pathway, based on its decision description and clearance type.