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)

AESKULISA ANA 8PRO

K-Number: K032469 · 2003-12-16

ApplicantAesku, Inc.
Decision Date2003-12-16
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA ANA 8PRO is the device name listed in this FDA 510(k) record. The listed applicant is Aesku, Inc.. It received FDA 510(k) clearance on 2003-12-16 under 510(k) number K032469. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKULISA ANA 8PRO?

AESKULISA ANA 8PRO is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Aesku, Inc.. The 510(k) number is K032469.

When did AESKULISA ANA 8PRO receive FDA 510(k) clearance?

AESKULISA ANA 8PRO received FDA 510(k) clearance on 2003-12-16, under 510(k) number K032469.

Who is the listed applicant for AESKULISA ANA 8PRO?

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

What is the FDA product code for AESKULISA ANA 8PRO?

The FDA product code for AESKULISA ANA 8PRO is LLL.

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 Aesku, 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.

K062217AESKULSKA BETA2-GLYCO-AK051492AESKULISA ASCA AK042644AESKULISA TTG A AND AESKULISA TTG GK040953AESKULISA ANA HEP-2K040463AESKULISA CARDIOLIPIN AGM

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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.

↑