OXY/STAR LOW FLOW BLENDER— 510(k) K952878

Substantially Equivalent

Infrasonics Corp.

FDA 510(k) clearance K952878 for OXY/STAR LOW FLOW BLENDER, Substantially Equivalent on 1995-09-25. Applicant: Infrasonics Corp.. Device class: 2.

Clearance details

Applicant: Infrasonics Corp.
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 1995-06-23
Decision date: 1995-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZR

K243917 — F&P Optiflow Air/Oxygen Flow Source2025-07-14
K241465 — Midas Flowmeter; eAVS2024-09-19
K231895 — Maxtec MaxBlend2+p2023-12-04
K230987 — FlowStar Analog Mixer Flowmeter2023-09-14
K222794 — FlowStar Touch Digital Mixer Flowmeter2023-07-28

More clearances from Infrasonics Corp.

K943106 — ADULT VENTILATOR1995-12-28
K934753 — STAR BREATHING CIRCUITS1993-10-27
K922654 — VENTILATOR ADULT STAR MODIFICATION1992-12-01
K923704 — INFANT STAR SERIES 5001992-10-22
K922477 — MODEL 105 VENTILATOR, MODIFICATION1992-08-24

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