Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODEL ME 300 MUSCLE TESTER

K-Number: K943535 · 1997-06-25

ApplicantRegulatory Strategies, Inc.
Decision Date1997-06-25
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL ME 300 MUSCLE TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory Strategies, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K943535. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ME 300 MUSCLE TESTER?

MODEL ME 300 MUSCLE TESTER is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Regulatory Strategies, Inc.. The 510(k) number is K943535.

When did MODEL ME 300 MUSCLE TESTER receive FDA 510(k) clearance?

MODEL ME 300 MUSCLE TESTER received FDA 510(k) clearance on 1997-06-25, under 510(k) number K943535.

Who is the listed applicant for MODEL ME 300 MUSCLE TESTER?

The FDA 510(k) record lists Regulatory Strategies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL ME 300 MUSCLE TESTER?

The FDA product code for MODEL ME 300 MUSCLE TESTER is HCC.

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

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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.

↑