MALLINCKRODT, GOODKNIGHT 418S— 510(k) K001845
Substantially EquivalentMallinckrodt Developpement France
FDA 510(k) clearance K001845 for MALLINCKRODT, GOODKNIGHT 418S, Substantially Equivalent on 2000-07-05. Applicant: Mallinckrodt Developpement France. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Developpement France
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Villers-Les-Nancy Cedex, FR
Recent devices under product code BZD
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
- K042184 — GOODKNIGHT H20, MODEL M-114600-00
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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.