FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K Number: K972084
·
Decision Jul 3, 1997
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
38
Applicant Total
39
Review Days
29
Basic Information
- Device Name
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
- K Number
- K972084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ALEXANDER MFG. CO.
- Date Received
- June 4, 1997
- Decision Date
- July 3, 1997
- Product Code
- FLN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLN), ordered by most recent decision date.
DripAssist Plus
FDA 510(k)
FDA Class 2
·General Hospital
DripAssist
FDA 510(k)
FDA Class 2
·General Hospital
FLUID LEVEL MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
LOW FLUID ALARM
FDA 510(k)
FDA Class 2
·General Hospital
ISSYS DRUG FLOW MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
LEVELERT II FLUID LEVEL SENSOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by ALEXANDER MFG. CO.
| K Number | Device Name | ||
|---|---|---|---|
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | Oct 21, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| 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 |
| K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P | Oct 20, 1997 | Substantially Equivalent |
| K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | Oct 20, 1997 | Substantially Equivalent |