PUREFILL OXYGEN COMPRESSOR— 510(k) K141967
Substantially EquivalentInovo, Inc.
FDA 510(k) clearance K141967 for PUREFILL OXYGEN COMPRESSOR, Substantially Equivalent on 2014-11-07. Applicant: Inovo, Inc.. Device class: 2.
Clearance details
- Applicant
- Inovo, Inc.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lehigh Acres, FL, US
Recent devices under product code CAW
view allMore clearances from Inovo, Inc.
view all- K113111 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
- K103392 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
- K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
- K051540 — INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
- K031983 — INOVO, INC, ECONOMIZER CONSERVING REGULATOR
Adverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141967
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141967.
Data sourced from openFDA. This site is unofficial and independent of the FDA.