FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPLACEMENT RECHARGEABLE BATTERY PACK'S
K Number: K925449
·
Decision Apr 29, 1993
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
18
Review Days
183
Basic Information
- Device Name
- REPLACEMENT RECHARGEABLE BATTERY PACK'S
- K Number
- K925449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PORTABLE POWER SYSTEMS, INC.
- Date Received
- October 28, 1992
- Decision Date
- April 29, 1993
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k)
FDA Class 2
·General Hospital
Plum Duo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital
RemunityPRO Pump for Remodulin® (treprostinil) Injection
FDA 510(k)
FDA Class 2
·General Hospital
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by PORTABLE POWER SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K970234 | SEALED LEAD ACID BATTERY PACK | May 2, 1997 | Substantially Equivalent |
| K946080 | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | Aug 2, 1995 | Substantially Equivalent |
| K945043 | BATTERY PACK #PMX120-18A | Jan 20, 1995 | Substantially Equivalent |
| K931483 | REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. | Feb 17, 1994 | Substantially Equivalent |
| K931348 | BATTERY PACK #1005NC | Feb 17, 1994 | Substantially Equivalent |
| K933065 | BATTERY PACK# S1009LA | 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 |
| K934439 | RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR | Feb 17, 1994 | Substantially Equivalent |
| K931484 | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S | Feb 17, 1994 | Substantially Equivalent |