COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION— 510(k) K873215
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K873215 for COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION, Substantially Equivalent on 1988-01-22. Applicant: Puritan Bennett Corp.. Device class: 2.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
Recent devices under product code CBK
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 CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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.