Medipart Lung Aerosol Kit MP-1012A-M
FDA 510(k) K851199 · Medipart Jerry Alexander
510(k) numberK851199
Submission
- Device name
- Medipart Lung Aerosol Kit MP-1012A-M
- Applicant
- Medipart Jerry Alexander
Cary, IL, US - Received
- March 26, 1985
- Decision date
- September 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYT
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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 |
|---|---|---|
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | 02/26/1990SE |
| K896125 | Medipart Disposable XENON-133 Rebreathing MP-0133MIYT · Traditional | 02/01/1990SE |
| K896476 | Disp. Radioaerosol Kit (MP-400-M) to Fit ShieldIYT · Traditional | 01/22/1990SE |
| K896475 | Disp. Radioaerosol Kit (MP-400) to Fit Lead ShieldIYT · Traditional | 01/22/1990SE |
| K896124 | Medipart Disposable XENON-133 Rebreathing MP-0133IYT · Traditional | 01/22/1990SE |
| K894138 | Medipart Disposable Aerosol System MP-070-PTDCAF · Traditional | 09/26/1989SE |
| K893532 | Resubmitted Radioaerosol Cont. System MP-963CBN · Traditional | 08/21/1989SE |
| K862795 | MP-070-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862794 | MP-070 Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862793 | MP-066-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
Questions and answers
When was Medipart Lung Aerosol Kit MP-1012A-M cleared by the FDA?
Medipart Lung Aerosol Kit MP-1012A-M (K851199) received a 510(k) decision of Substantially Equivalent on September 10, 1985, 168 days after the submission was received.
What is the product code of K851199?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.