ACUSTIM— 510(k) K014273

Substantially Equivalent

S.H.P. Intl. Pty., Ltd.

FDA 510(k) clearance K014273 for ACUSTIM, Substantially Equivalent on 2002-06-12. Applicant: S.H.P. Intl. Pty., Ltd.. Device class: Unclassified.

Clearance details

Applicant: S.H.P. Intl. Pty., Ltd.
Product code: Code BWK
Device class: Unclassified
Advisory panel: Unknown
Date received: 2001-12-27
Decision date: 2002-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullarton, S.A., AU

Download summary PDF View on FDA.gov ↗

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