GOODKNIGHT H20, MODEL M-114600-00— 510(k) K042184
Substantially EquivalentMallinckrodt Developpement France
FDA 510(k) clearance K042184 for GOODKNIGHT H20, MODEL M-114600-00, Substantially Equivalent on 2005-01-10. Applicant: Mallinckrodt Developpement France. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Developpement France
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Villers-Les-Nancy Cedex, FR
Recent devices under product code BTT
view allMore clearances from Mallinckrodt Developpement France
view all- K082237 — PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
- K080439 — SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
- K071575 — SANDMAN INTRO
- K063501 — KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
- K041819 — GOODKNIGHT 425, MODELM-114500-00
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.