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FDA 510(k)

SIM

K-Number: K130951 · 2013-08-22

ApplicantSimavita Pty Limited
Decision Date2013-08-22
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIM is the device name listed in this FDA 510(k) record. The listed applicant is Simavita Pty Limited. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K130951. The device is classified under product code KPN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIM?

SIM is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Simavita Pty Limited. The 510(k) number is K130951.

When did SIM receive FDA 510(k) clearance?

SIM received FDA 510(k) clearance on 2013-08-22, under 510(k) number K130951.

Who is the listed applicant for SIM?

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

What is the FDA product code for SIM?

The FDA product code for SIM is KPN.

Related PubMed Literature

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.

PMID: 41055689Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review.Therapeutic innovation & regulatory science ()PMID: 39300713Medical device similarity analysis: a promising approach to medical device equivalence regulation.Expert review of medical devices ()PMID: 37496031Adapting modeling and simulation credibility standards to computational systems biology.Journal of translational medicine ()PMID: 35349537Prospective Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscle: A 510(k) Approval Study with U.S. Food and Drug Administration Investigational Device Exemption.Plastic and reconstructive surgery ()

Related Devices (Code: KPN)

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.

K971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.K962770UROSURGE ACUTRAINERPrinceton Regulatory Assoc.K962416DRYTIME FOR BLADDER CONTROL SILENTBio-Systems ResearchK955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., Inc.K943559REMOTE A'LERTHealth Sense Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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