Xenon Xe 127/XE 133 Gas Dispenser
FDA 510(k) K843640 · Mallinckrodt Critical Care
510(k) numberK843640
Submission
- Device name
- Xenon Xe 127/XE 133 Gas Dispenser
- Applicant
- Mallinckrodt Critical Care
St. Louis, MO, US - Received
- September 17, 1984
- Decision date
- January 14, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K200916 | Patient Administration SetIYT · Traditional | Cyclomedica Australia Pty, Ltd. | 09/01/2020SE |
| K953513 | Xenon CircuitIYT · Traditional | King Systems Corp. | 11/03/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | Intertech Resources, Inc. | 08/11/1995SE |
| K914747 | Xenon CircuitIYT · Traditional | Gibeck, Inc. | 02/27/1992SE |
| K913416 | Tetley Patient Administration SetIYT · Traditional | Tetley Medical , Ltd. | 10/28/1991SE |
| K912626 | Bolus Xenon CircuitIYT · Traditional | Vital Signs, Inc. | 08/02/1991SE |
| K904684 | Amici Krypton Administration System, ModificationIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903805 | Amici Xenon Administration SetIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | Amici, Inc. | 10/03/1990SE |
More from Amici, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880343 | Burney Gallbladder Catheter KitFGE · Traditional | 05/01/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | 02/02/1988SE |
| K874514 | Hi-Lo Temp(R) General Purpose Temperature ProbeFLL · Traditional | 01/29/1988SE |
| K874568 | Hi-Lo Temp(R) Model 8700 Patient Temp MonitorFLL · Traditional | 01/06/1988SE |
| K874404 | Hi-Lo Temp(R) Skin Temperature SensorFLL · Traditional | 11/06/1987SE |
| K873461 | Laser-Flex(Tm) Tracheal Tube (Cuffed)BTR · Traditional | 11/06/1987SE |
| K873833 | Thermocouple AdapterFLL · Traditional | 11/03/1987SE |
| K873004 | Guiding CatheterDQO · Traditional | 09/15/1987SE |
| K871204 | Cuffed Tracheal Tube (Multiple)BTR · Traditional | 04/21/1987SE |
| K862666 | Uncuffed Laser Resisteant Tracheal Tube(Tentative)BTR · Traditional | 08/01/1986SE |
Questions and answers
When was Xenon Xe 127/XE 133 Gas Dispenser cleared by the FDA?
Xenon Xe 127/XE 133 Gas Dispenser (K843640) received a 510(k) decision of Substantially Equivalent on January 14, 1985, 119 days after the submission was received.
What is the product code of K843640?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.