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)

SLEEPMASTER

K-Number: K911386 · 1992-04-24

Decision Date1992-04-24
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPMASTER is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Monitoring Systems, Inc.. It received FDA 510(k) clearance on 1992-04-24 under 510(k) number K911386. 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 SLEEPMASTER?

SLEEPMASTER is a medical device that received FDA 510(k) clearance on 1992-04-24. The listed applicant is Biomedical Monitoring Systems, Inc.. The 510(k) number is K911386.

When did SLEEPMASTER receive FDA 510(k) clearance?

SLEEPMASTER received FDA 510(k) clearance on 1992-04-24, under 510(k) number K911386.

Who is the listed applicant for SLEEPMASTER?

The FDA 510(k) record lists Biomedical Monitoring Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLEEPMASTER?

The FDA product code for SLEEPMASTER 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.

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.

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.

↑