Alexander Manufacturing Co. Battery Part Number H134
FDA 510(k) K981728 · Alexander Mfg. Co.
510(k) numberK981728
Submission
- Device name
- Alexander Manufacturing Co. Battery Part Number H134
- Applicant
- Alexander Mfg. Co.
Mason City, IA, US - Received
- May 15, 1998
- Decision date
- June 26, 1998
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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More from Linshom Medical, Inc.
| 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 |
| 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 |
| K972789 | Alexander Manufacturing Co. Rechargeable Battery Part Number GL600-0016DRT · Traditional | 10/17/1997SE |
Questions and answers
When was Alexander Manufacturing Co. Battery Part Number H134 cleared by the FDA?
Alexander Manufacturing Co. Battery Part Number H134 (K981728) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on June 26, 1998, 42 days after the submission was received.
What is the product code of K981728?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.