Peripheral Nerve Stimulator Model A400
FDA 510(k) K852962 · Fisher & Paykel Allied Products , Ltd.
510(k) numberK852962
Submission
- Device name
- Peripheral Nerve Stimulator Model A400
- Applicant
- Fisher & Paykel Allied Products , Ltd.
Auckland, New Zealand, NZ - Received
- July 12, 1985
- Decision date
- December 9, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXN – Stimulator, Nerve, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
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|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 10/16/2022SE |
| K162086 | MultiStim ECOBXN · Traditional | PAJUNK GmbH Medizintechnologie | 01/06/2017SE |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special | Easy Med Instrument Co., Ltd. | 05/13/2016SE |
| K143095 | MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional | Halyard Health, Inc. | 03/24/2015SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 11/06/2014SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | Sunmed, LLC | 03/28/2013SE |
| K111985 | Myoguide System Model 8008BXN · Traditional | Intronix Technologies Corp. | 12/30/2011SE |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 02/17/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/03/2009SE |
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| K880702 | Model MR430 Special Purpose Humid. Heater BasesBTT · Traditional | 07/08/1988SE |
| K872138 | MR630 Enhanced Dual Servo Heater HumidifierBTT · Traditional | 10/07/1987SE |
| K872139 | MR420 Transport HumidifierBTT · Traditional | 09/15/1987SE |
| K863377 | MR338 Servo Heated Delivery HumidifierBTT · Traditional | 02/20/1987SE |
| K870055 | MR590 Dual Hose Heater Power PackBTT · Traditional | 02/10/1987SE |
| K862923 | MR620 Dual Servo Heated Anaesthesia HumidifierBTT · Traditional | 09/23/1986SE |
| K851879 | Heated Respiratory HumidifierBTT · Traditional | 09/03/1985SE |
| K850647 | Heated Respiratory Humififier MR440BTT · Traditional | 03/12/1985SE |
| K843903 | Heated Respiratory Humidifier MR428BTT · Traditional | 10/22/1984SE |
| K832928 | Servo Heated Respiratory HumidifierBTT · Traditional | 11/25/1983SE |
Questions and answers
When was Peripheral Nerve Stimulator Model A400 cleared by the FDA?
Peripheral Nerve Stimulator Model A400 (K852962) received a 510(k) decision of Substantially Equivalent on December 9, 1985, 150 days after the submission was received.
What is the product code of K852962?
The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.