MODEL 7200A WITH PULSE OXIMETRY— 510(k) K873065
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K873065 for MODEL 7200A WITH PULSE OXIMETRY, Substantially Equivalent on 1987-10-26. Applicant: Puritan Bennett Corp.. Device class: 2.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
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More 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 DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.