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)

PERITRON PERINEOMETER MODEL 9300V OR 9300A

K-Number: K983052 · 1998-10-19

ApplicantCardio Design Pty. , Ltd.
Decision Date1998-10-19
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERITRON PERINEOMETER MODEL 9300V OR 9300A is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Design Pty. , Ltd.. It received FDA 510(k) clearance on 1998-10-19 under 510(k) number K983052. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERITRON PERINEOMETER MODEL 9300V OR 9300A?

PERITRON PERINEOMETER MODEL 9300V OR 9300A is a medical device that received FDA 510(k) clearance on 1998-10-19. The listed applicant is Cardio Design Pty. , Ltd.. The 510(k) number is K983052.

When did PERITRON PERINEOMETER MODEL 9300V OR 9300A receive FDA 510(k) clearance?

PERITRON PERINEOMETER MODEL 9300V OR 9300A received FDA 510(k) clearance on 1998-10-19, under 510(k) number K983052.

Who is the listed applicant for PERITRON PERINEOMETER MODEL 9300V OR 9300A?

The FDA 510(k) record lists Cardio Design Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERITRON PERINEOMETER MODEL 9300V OR 9300A?

The FDA product code for PERITRON PERINEOMETER MODEL 9300V OR 9300A is HIR.

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 Cardio Design Pty. , Ltd. 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.

K945611PERITRON

Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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.

↑