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)

THERMAL ANGEL

K-Number: K984640 · 1999-07-01

Decision Date1999-07-01
Product CodeBSB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

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 1999-07-01 under 510(k) number K984640. 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 THERMAL ANGEL?

THERMAL ANGEL is a medical device that received FDA 510(k) clearance on 1999-07-01. The listed applicant is Estill Medical Technologies, Inc.. The 510(k) number is K984640.

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

THERMAL ANGEL received FDA 510(k) clearance on 1999-07-01, under 510(k) number K984640.

Who is the listed applicant for 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 THERMAL ANGEL?

The FDA product code for 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.

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.

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.

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.

↑