ALPHAMED GEMINI SENSOR, SNORING SENSOR— 510(k) K990321

Name: FDA 510(k) clearance K990321
Creator: U.S. Food and Drug Administration
Published: 1999-06-01

Substantially Equivalent

Alphamed, Inc.

FDA 510(k) clearance K990321 for ALPHAMED GEMINI SENSOR, SNORING SENSOR, Substantially Equivalent on 1999-06-01. Applicant: Alphamed, Inc.. Device class: 2.

Clearance details

Applicant: Alphamed, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1999-02-01
Decision date: 1999-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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