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FDA 510(k)

FINESSE PERSONAL INSULIN DELIVERY PATCH

K-Number: K111924 · 2012-04-10

ApplicantCalibra Medical, Inc.
Decision Date2012-04-10
Product CodeOPP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FINESSE PERSONAL INSULIN DELIVERY PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Calibra Medical, Inc.. It received FDA 510(k) clearance on 2012-04-10 under 510(k) number K111924. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINESSE PERSONAL INSULIN DELIVERY PATCH?

FINESSE PERSONAL INSULIN DELIVERY PATCH is a medical device that received FDA 510(k) clearance on 2012-04-10. The listed applicant is Calibra Medical, Inc.. The 510(k) number is K111924.

When did FINESSE PERSONAL INSULIN DELIVERY PATCH receive FDA 510(k) clearance?

FINESSE PERSONAL INSULIN DELIVERY PATCH received FDA 510(k) clearance on 2012-04-10, under 510(k) number K111924.

Who is the listed applicant for FINESSE PERSONAL INSULIN DELIVERY PATCH?

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

What is the FDA product code for FINESSE PERSONAL INSULIN DELIVERY PATCH?

The FDA product code for FINESSE PERSONAL INSULIN DELIVERY PATCH is OPP.

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 Calibra Medical, Inc. 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.

K100947FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000K093065FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000

Related Devices (Code: OPP)

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.

K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SAK243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SAK233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SAK163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbHK100947FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000Calibra Medical, Inc.K093065FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000Calibra Medical, 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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