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)

ACCU-CHEK SPIRIT

K-Number: K042887 · 2005-03-18

ApplicantDisetronic Medical Systems AG
Decision Date2005-03-18
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK SPIRIT is the device name listed in this FDA 510(k) record. The listed applicant is Disetronic Medical Systems AG. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K042887. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK SPIRIT?

ACCU-CHEK SPIRIT is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is Disetronic Medical Systems AG. The 510(k) number is K042887.

When did ACCU-CHEK SPIRIT receive FDA 510(k) clearance?

ACCU-CHEK SPIRIT received FDA 510(k) clearance on 2005-03-18, under 510(k) number K042887.

Who is the listed applicant for ACCU-CHEK SPIRIT?

The FDA 510(k) record lists Disetronic Medical Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-CHEK SPIRIT?

The FDA product code for ACCU-CHEK SPIRIT is LZG.

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 Disetronic Medical Systems AG 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.

K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICEK070189ACCU-CHEK ULTRAFLEX INFUSION SETK063146ACCU-CHEK LINKASSISTK060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWAK043000MODIFICATION TO D-TRONPLUSK033892ULTRAFLEX INFUSION SET

View all 12 devices →

Related Devices (Code: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

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.

↑