FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
K Number: K982896
·
Decision Oct 21, 1998
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
39
Review Days
65
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Basic Information
- Device Name
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
- K Number
- K982896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Alexander Mfg. Co.
- Date Received
- August 17, 1998
- Decision Date
- October 21, 1998
- Product Code
- LDD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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Other Clearances by Alexander Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K981776 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X | Aug 3, 1998 | Substantially Equivalent |
| K981728 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 | Jun 26, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K980224 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 | Apr 2, 1998 | Substantially Equivalent |
| K974061 | RECHARGEABLE BATTERY PART NUMBER GL825-200 | Jan 16, 1998 | Substantially Equivalent |
| K973851 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 | Jan 5, 1998 | Substantially Equivalent |
| K973850 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | Nov 12, 1997 | Substantially Equivalent |
| K972746 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 | Oct 21, 1997 | Substantially Equivalent |
| K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | Oct 20, 1997 | Substantially Equivalent |
| K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P | Oct 20, 1997 | Substantially Equivalent |
| K972787 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P | Oct 17, 1997 | Substantially Equivalent |