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FDA 510(k)

DINAMAP PLUS VITAL SIGNS MONOITOR

K-Number: K943709 · 1995-06-16

ApplicantCritikon Company, LLC
Decision Date1995-06-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DINAMAP PLUS VITAL SIGNS MONOITOR 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 1995-06-16 under 510(k) number K943709. 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 DINAMAP PLUS VITAL SIGNS MONOITOR?

DINAMAP PLUS VITAL SIGNS MONOITOR is a medical device that received FDA 510(k) clearance on 1995-06-16. The listed applicant is Critikon Company, LLC. The 510(k) number is K943709.

When did DINAMAP PLUS VITAL SIGNS MONOITOR receive FDA 510(k) clearance?

DINAMAP PLUS VITAL SIGNS MONOITOR received FDA 510(k) clearance on 1995-06-16, under 510(k) number K943709.

Who is the listed applicant for DINAMAP PLUS VITAL SIGNS MONOITOR?

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 VITAL SIGNS MONOITOR?

The FDA product code for DINAMAP PLUS VITAL SIGNS MONOITOR 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340K933404CRITIKON CENTRAL STATIN MONITOR

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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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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