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)

IQVITALS AND IQVITALS SYSTEM

K-Number: K100913 · 2010-05-26

Decision Date2010-05-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IQVITALS AND IQVITALS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Medical Technology Corp.. It received FDA 510(k) clearance on 2010-05-26 under 510(k) number K100913. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQVITALS AND IQVITALS SYSTEM?

IQVITALS AND IQVITALS SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-26. The listed applicant is Brentwood Medical Technology Corp.. The 510(k) number is K100913.

When did IQVITALS AND IQVITALS SYSTEM receive FDA 510(k) clearance?

IQVITALS AND IQVITALS SYSTEM received FDA 510(k) clearance on 2010-05-26, under 510(k) number K100913.

Who is the listed applicant for IQVITALS AND IQVITALS SYSTEM?

The FDA 510(k) record lists Brentwood Medical Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQVITALS AND IQVITALS SYSTEM?

The FDA product code for IQVITALS AND IQVITALS SYSTEM is DXN.

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 Brentwood Medical Technology Corp. 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.

View all 7 devices →

Related Devices (Code: DXN)

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.

↑