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)

ALPHAMED GEMINI SENSOR, SNORING SENSOR

K-Number: K990321 · 1999-06-01

ApplicantAlphamed, Inc.
Decision Date1999-06-01
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ALPHAMED GEMINI SENSOR, SNORING SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Alphamed, Inc.. It received FDA 510(k) clearance on 1999-06-01 under 510(k) number K990321. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHAMED GEMINI SENSOR, SNORING SENSOR?

ALPHAMED GEMINI SENSOR, SNORING SENSOR is a medical device that received FDA 510(k) clearance on 1999-06-01. The listed applicant is Alphamed, Inc.. The 510(k) number is K990321.

When did ALPHAMED GEMINI SENSOR, SNORING SENSOR receive FDA 510(k) clearance?

ALPHAMED GEMINI SENSOR, SNORING SENSOR received FDA 510(k) clearance on 1999-06-01, under 510(k) number K990321.

Who is the listed applicant for ALPHAMED GEMINI SENSOR, SNORING SENSOR?

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

What is the FDA product code for ALPHAMED GEMINI SENSOR, SNORING SENSOR?

The FDA product code for ALPHAMED GEMINI SENSOR, SNORING SENSOR is MNR.

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 Alphamed, 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.

K190210Tear Pool Dissolvable Punctum PlugsK091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000K926446EZ PUMP

Related Devices (Code: MNR)

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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.

↑