APNOESCREEN PRO, ALPHA SCREEN PRO— 510(k) K000396

Name: FDA 510(k) clearance K000396
Creator: U.S. Food and Drug Administration
Published: 2000-12-27

Substantially Equivalent

Erich Jaeger, Inc.

FDA 510(k) clearance K000396 for APNOESCREEN PRO, ALPHA SCREEN PRO, Substantially Equivalent on 2000-12-27. Applicant: Erich Jaeger, Inc.. Device class: 2.

Clearance details

Applicant: Erich Jaeger, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2000-02-07
Decision date: 2000-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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