AIRWAY PRESSURE MONITOR— 510(k) K761199
Substantially EquivalentDraeger Medical, Inc.
FDA 510(k) clearance K761199 for AIRWAY PRESSURE MONITOR, Substantially Equivalent on 1977-02-28. Applicant: Draeger Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical, Inc.
- Product code
- Code GAP
- Device class
- Class 2
- Regulation
- 21 CFR 878.5030
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Draeger Medical, Inc.
view allAdverse events under product code GAP
product code GAP- Death
- 3
- Injury
- 491
- Malfunction
- 2,253
- Total
- 2,747
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.