RESPALERT— 510(k) K992618

Substantially Equivalent

Harwill Medical (Pty) , Ltd.

FDA 510(k) clearance K992618 for RESPALERT, Substantially Equivalent on 1999-10-29. Applicant: Harwill Medical (Pty) , Ltd.. Device class: 2.

Clearance details

Applicant: Harwill Medical (Pty) , Ltd.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 1999-08-04
Decision date: 1999-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, 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.