STAR CALC— 510(k) K875027

Substantially Equivalent

Infrasonics Corp.

FDA 510(k) clearance K875027 for STAR CALC, Substantially Equivalent on 1988-08-16. Applicant: Infrasonics Corp.. Device class: 2.

Clearance details

Applicant: Infrasonics Corp.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1987-12-07
Decision date: 1988-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Infrasonics Corp.

K943106 — ADULT VENTILATOR1995-12-28
K952878 — OXY/STAR LOW FLOW BLENDER1995-09-25
K934753 — STAR BREATHING CIRCUITS1993-10-27
K922654 — VENTILATOR ADULT STAR MODIFICATION1992-12-01
K923704 — INFANT STAR SERIES 5001992-10-22

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