INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR— 510(k) K060751

Name: FDA 510(k) clearance K060751
Creator: U.S. Food and Drug Administration
Published: 2006-07-18

Substantially Equivalent

Inovo, Inc.

FDA 510(k) clearance K060751 for INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR, Substantially Equivalent on 2006-07-18. Applicant: Inovo, Inc.. Device class: 2.

Clearance details

Applicant: Inovo, Inc.
Product code: Code NFB
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2006-03-21
Decision date: 2006-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060751

K-number listed on FDA's recall record

Z-2099-2019 — Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.Class II·Terminated·Inovo, Inc·20190426

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060751.

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