PORTABLE OXYGEN SYSTEM— 510(k) K830844
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K830844 for PORTABLE OXYGEN SYSTEM, Substantially Equivalent on 1983-05-27. Applicant: Puritan Bennett Corp.. Device class: 1.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code CAN
- Device class
- Class 1
- Regulation
- 21 CFR 868.2700
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CAN
view allMore clearances from Puritan Bennett Corp.
view all- K063650 — VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
- K053388 — MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
- K023225 — PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
- K022103 — PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
- K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
Adverse events under product code CAN
product code CAN- Death
- 4
- Other
- 1
- Total
- 5
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.