Alexander Manufacturing Co. Rechargeable Battery #M12/630
FDA 510(k) K973851 · Alexander Mfg. Co.
510(k) numberK973851
Submission
- Device name
- Alexander Manufacturing Co. Rechargeable Battery #M12/630
- Applicant
- Alexander Mfg. Co.
Mason City, IA, US - Received
- October 8, 1997
- Decision date
- January 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
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| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
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More from Deka Research and Development Corp.
| 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 |
| 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 |
| K972789 | Alexander Manufacturing Co. Rechargeable Battery Part Number GL600-0016DRT · Traditional | 10/17/1997SE |
Questions and answers
When was Alexander Manufacturing Co. Rechargeable Battery #M12/630 cleared by the FDA?
Alexander Manufacturing Co. Rechargeable Battery #M12/630 (K973851) received a 510(k) decision of Substantially Equivalent on January 5, 1998, 89 days after the submission was received.
What is the product code of K973851?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.