INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997— 510(k) K082888
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K082888 for INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997, Substantially Equivalent on 2008-11-26. Applicant: Draeger Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- 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
- Special
- Location
- Andover, MA, US
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More clearances from Draeger Medical Systems, Inc.
view allAdverse 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.