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)

PHEM-ALERT

K-Number: K032161 · 2003-09-30

ApplicantFemtek,Llc.
Decision Date2003-09-30
Product CodeLNW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHEM-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Femtek,Llc.. It received FDA 510(k) clearance on 2003-09-30 under 510(k) number K032161. The device is classified under product code LNW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHEM-ALERT?

PHEM-ALERT is a medical device that received FDA 510(k) clearance on 2003-09-30. The listed applicant is Femtek,Llc.. The 510(k) number is K032161.

When did PHEM-ALERT receive FDA 510(k) clearance?

PHEM-ALERT received FDA 510(k) clearance on 2003-09-30, under 510(k) number K032161.

Who is the listed applicant for PHEM-ALERT?

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

What is the FDA product code for PHEM-ALERT?

The FDA product code for PHEM-ALERT is LNW.

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 Femtek,Llc. 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.

K012230PHEM-ALERT

Related Devices (Code: LNW)

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.

K012230PHEM-ALERTFemtek,Llc.K960648PHEM-CHEKFemtek, Inc.K850858OB-PH - PH TEST PAPERUro Pharmaceuticals, 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.

↑