MEDICAL/SURGICAL SUCTION SYSTEM— 510(k) K851384
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K851384 for MEDICAL/SURGICAL SUCTION SYSTEM, Substantially Equivalent on 1985-05-08. Applicant: Puritan Bennett Corp.. Device class: 2.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code GCX
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
Recent devices under product code GCX
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 GCX
product code GCX- Death
- 9
- Malfunction
- 592
- Other
- 2
- Total
- 603
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.