BABYTHERM 8000 LDR— 510(k) K980886
Substantially EquivalentDraeger Medical, Inc.
FDA 510(k) clearance K980886 for BABYTHERM 8000 LDR, Substantially Equivalent on 1998-05-29. Applicant: Draeger Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical, Inc.
- Product code
- Code FMZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Recent devices under product code FMZ
view allMore clearances from Draeger Medical, Inc.
view allAdverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
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.