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)

ZIEHM VISION

K-Number: K011292 · 2001-06-20

ApplicantZiehm International, Inc.
Decision Date2001-06-20
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIEHM VISION is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 2001-06-20 under 510(k) number K011292. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIEHM VISION?

ZIEHM VISION is a medical device that received FDA 510(k) clearance on 2001-06-20. The listed applicant is Ziehm International, Inc.. The 510(k) number is K011292.

When did ZIEHM VISION receive FDA 510(k) clearance?

ZIEHM VISION received FDA 510(k) clearance on 2001-06-20, under 510(k) number K011292.

Who is the listed applicant for ZIEHM VISION?

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

What is the FDA product code for ZIEHM VISION?

The FDA product code for ZIEHM VISION is OWB.

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 Ziehm International, 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.

K910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTORK902196MODIFIED STICK-GARD SAFETY NEEDLEK894021MOBILE X-RAY UNITK894041PUMP-JECT SYRINGE WITH LUER-LOCKK890620STICK-GARD SAFETY NEEDLEK882133MAMMO M

View all 16 devices →

Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, 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.

↑