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
149
Registration Numbers
149
Same Product Code
847
Applicant Total
18
Review Days
183
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
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.
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)
FDA Class 2
·General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library
FDA 510(k)
FDA Class 2
·General Hospital
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 Solo Precision IV Pump
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 |
| 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 |