Bolus Xenon Circuit
FDA 510(k) K912626 · Vital Signs, Inc.
510(k) numberK912626
Submission
- Device name
- Bolus Xenon Circuit
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- June 13, 1991
- Decision date
- August 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
| 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 |
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | Medipart Jerry Alexander | 02/26/1990SE |
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Questions and answers
When was Bolus Xenon Circuit cleared by the FDA?
Bolus Xenon Circuit (K912626) received a 510(k) decision of Substantially Equivalent on August 2, 1991, 50 days after the submission was received.
What is the product code of K912626?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.