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)

MODIFICATION TO THERMAL ANGEL

K-Number: K012031 · 2001-07-26

ApplicantEstill Medical Technologies, Inc.
Decision Date2001-07-26
Product CodeBSB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THERMAL ANGEL is the device name listed in this FDA 510(k) record. The listed applicant is Estill Medical Technologies, Inc.. It received FDA 510(k) clearance on 2001-07-26 under 510(k) number K012031. The device is classified under product code BSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO THERMAL ANGEL?

MODIFICATION TO THERMAL ANGEL is a medical device that received FDA 510(k) clearance on 2001-07-26. The listed applicant is Estill Medical Technologies, Inc.. The 510(k) number is K012031.

When did MODIFICATION TO THERMAL ANGEL receive FDA 510(k) clearance?

MODIFICATION TO THERMAL ANGEL received FDA 510(k) clearance on 2001-07-26, under 510(k) number K012031.

Who is the listed applicant for MODIFICATION TO THERMAL ANGEL?

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

What is the FDA product code for MODIFICATION TO THERMAL ANGEL?

The FDA product code for MODIFICATION TO THERMAL ANGEL is BSB.

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 Estill Medical Technologies, 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.

K984640THERMAL ANGEL

Related Devices (Code: BSB)

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.

K112639THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.K090508THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.K062774BELMONT BUDDY PLUS FLUID WARMERBelmont Instrument Corp.K052547BELMONT BUDDY FLUID WARMERBelmont Instrument Corp.K031478MICROHEATERBelmont Instrument Corp.K020060ASTOFLONats Corp.

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.

↑