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FDA 510(k)

MPS450 MULTIPARAMETER SIMULATOR

K-Number: K103336 · 2011-04-13

ApplicantFluke Biomedical
Decision Date2011-04-13
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MPS450 MULTIPARAMETER SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Fluke Biomedical. It received FDA 510(k) clearance on 2011-04-13 under 510(k) number K103336. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPS450 MULTIPARAMETER SIMULATOR?

MPS450 MULTIPARAMETER SIMULATOR is a medical device that received FDA 510(k) clearance on 2011-04-13. The listed applicant is Fluke Biomedical. The 510(k) number is K103336.

When did MPS450 MULTIPARAMETER SIMULATOR receive FDA 510(k) clearance?

MPS450 MULTIPARAMETER SIMULATOR received FDA 510(k) clearance on 2011-04-13, under 510(k) number K103336.

Who is the listed applicant for MPS450 MULTIPARAMETER SIMULATOR?

The FDA 510(k) record lists Fluke Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MPS450 MULTIPARAMETER SIMULATOR?

The FDA product code for MPS450 MULTIPARAMETER SIMULATOR is DRT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fluke Biomedical 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.

K121860ESA615K121722ESA620 ELECTRICAL SAFETY ANALYZERK110429PROSIM 4, PROSIM 6, PROSIM 8K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSK072114IMPULSE 6000D/7000DP

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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