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)

SLEEPMINDER BREATHING FREQUENCY INDICATOR

K-Number: K103631 · 2011-07-21

ApplicantBiancamed Limited
Decision Date2011-07-21
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPMINDER BREATHING FREQUENCY INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Biancamed Limited. It received FDA 510(k) clearance on 2011-07-21 under 510(k) number K103631. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPMINDER BREATHING FREQUENCY INDICATOR?

SLEEPMINDER BREATHING FREQUENCY INDICATOR is a medical device that received FDA 510(k) clearance on 2011-07-21. The listed applicant is Biancamed Limited. The 510(k) number is K103631.

When did SLEEPMINDER BREATHING FREQUENCY INDICATOR receive FDA 510(k) clearance?

SLEEPMINDER BREATHING FREQUENCY INDICATOR received FDA 510(k) clearance on 2011-07-21, under 510(k) number K103631.

Who is the listed applicant for SLEEPMINDER BREATHING FREQUENCY INDICATOR?

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

What is the FDA product code for SLEEPMINDER BREATHING FREQUENCY INDICATOR?

The FDA product code for SLEEPMINDER BREATHING FREQUENCY INDICATOR is BZQ.

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

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart 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.

↑