SPIRO PRO— 510(k) K000648

Substantially Equivalent

Erich Jaeger GmbH

FDA 510(k) clearance K000648 for SPIRO PRO, Substantially Equivalent on 2000-03-29. Applicant: Erich Jaeger GmbH. Device class: 2.

Clearance details

Applicant: Erich Jaeger GmbH
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2000-02-28
Decision date: 2000-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.