Alexander Mfg. Rechargeable Battery (Model M3/T)
FDA 510(k) K970784 · Alexander Mfg. Co.
510(k) numberK970784
Submission
- Device name
- Alexander Mfg. Rechargeable Battery (Model M3/T)
- Applicant
- Alexander Mfg. Co.
Mason City, IA, US - Received
- March 4, 1997
- Decision date
- May 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K982896 | Alexander Manufacturing Co. Rechargeable Battery Part Number LP9LDD · Traditional | 10/21/1998ST |
| K981776 | Alexander Manufacturing Co. Battery Part Number MC146XFRN · Traditional | 08/03/1998SE |
| K981728 | Alexander Manufacturing Co. Battery Part Number H134BZQ · Traditional | 06/26/1998ST |
| K980224 | Alexander Manufacturing Co. Rechargeable Battery Part Number MS822MOQ · Traditional | 04/02/1998SE |
| K974061 | Rechargeable Battery Part Number GL825-200DXN · Traditional | 01/16/1998SE |
| K973851 | Alexander Manufacturing Co. Rechargeable Battery #M12/630FRN · Traditional | 01/05/1998SE |
| K973850 | Alexander Manufacturing Co. Rechargeable Battery #M007HFO · Traditional | 11/12/1997SE |
| K972746 | Alexander Manufacturing Co. Rechargeable Battery Part Number LP6/100DPS · Traditional | 10/21/1997SE |
| K972780 | Alexander Manufacturing Co. Rechargeable Battery Part Number GL625MRZ · Traditional | 10/20/1997SE |
| K972779 | Alexander Manufacturing Co. Rechargeable Battery Part Number MS3030-PMRZ · Traditional | 10/20/1997SE |
Questions and answers
When was Alexander Mfg. Rechargeable Battery (Model M3/T) cleared by the FDA?
Alexander Mfg. Rechargeable Battery (Model M3/T) (K970784) received a 510(k) decision of Substantially Equivalent on May 14, 1997, 71 days after the submission was received.
What is the product code of K970784?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.