FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BATTERY PACK #PMX120-18A
K Number: K945043
·
Decision Jan 20, 1995
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
18
Review Days
98
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Basic Information
- Device Name
- BATTERY PACK #PMX120-18A
- K Number
- K945043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Portable Power Systems, Inc.
- Date Received
- October 14, 1994
- Decision Date
- January 20, 1995
- Product Code
- IZL
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by Portable Power Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970234 | SEALED LEAD ACID BATTERY PACK | May 2, 1997 | Substantially Equivalent |
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| K931348 | BATTERY PACK #1005NC | Feb 17, 1994 | Substantially Equivalent |
| K931483 | REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. | Feb 17, 1994 | Substantially Equivalent |
| K933065 | BATTERY PACK# S1009LA | Feb 17, 1994 | Substantially Equivalent |
| K934439 | RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR | Feb 17, 1994 | Substantially Equivalent |
| K932823 | BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK | Feb 17, 1994 | Substantially Equivalent |
| K934015 | RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB | Feb 17, 1994 | Substantially Equivalent |
| K934508 | BATTERY PACK# S1024NC | Feb 17, 1994 | Substantially Equivalent |
| K931484 | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S | Feb 17, 1994 | Substantially Equivalent |