Amici Krypton Administration System, Modification
FDA 510(k) K904684 · Amici, Inc.
510(k) numberK904684
Submission
- Device name
- Amici Krypton Administration System, Modification
- Applicant
- Amici, Inc.
Spring City, PA, US - Received
- August 15, 1990
- Decision date
- January 14, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYT
| 510(k) | Device | Applicant | Decision |
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| K253942 | Pulmonex II Xenon System (132-503)IYT · Traditional | Mirion Technologies (Capintec), Inc. | 07/07/2026SE |
| 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 |
| K903805 | Amici Xenon Administration SetIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | Amici, Inc. | 10/03/1990SE |
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | Medipart Jerry Alexander | 02/26/1990SE |
More from Medipart Jerry Alexander
| 510(k) | Device | Decision |
|---|---|---|
| K063716 | Aerosol SystemCAF · Traditional | 12/28/2007SE |
| K952910 | The Swirler NebulizerCAF · Traditional | 03/19/1997SE |
| K952893 | The Swirler Aerosol SystemCAF · Traditional | 11/03/1995SE |
| K903805 | Amici Xenon Administration SetIYT · Traditional | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | 10/03/1990SE |
| K872920 | Amici Krypton Administration System*IYT · Traditional | 02/12/1988SE |
| K865084 | Amici Xenon Rebreathing System*IYT · Traditional | 03/03/1987SE |
Questions and answers
When was Amici Krypton Administration System, Modification cleared by the FDA?
Amici Krypton Administration System, Modification (K904684) received a 510(k) decision of Substantially Equivalent on January 14, 1991, 152 days after the submission was received.
What is the product code of K904684?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.