INVACARE PRO, COMPACT AND PORTABLE DESKTOP— 510(k) K042483
Substantially EquivalentInvacare Corporation
FDA 510(k) clearance K042483 for INVACARE PRO, COMPACT AND PORTABLE DESKTOP, Substantially Equivalent on 2005-01-06. Applicant: Invacare Corporation. Device class: 2.
Clearance details
- Applicant
- Invacare Corporation
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elyria, OH, US
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- K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
Adverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.