FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIPOWERR RECHARGEABLE BATTERY PACK
K Number: K935111
·
Decision Mar 28, 1994
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
3
Review Days
154
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
- UNIPOWERR RECHARGEABLE BATTERY PACK
- K Number
- K935111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unipower Corp.
- Date Received
- October 25, 1993
- Decision Date
- March 28, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDD), ordered by most recent decision date.
Switched Internal Paddles
FDA 510(k)
FDA Class 2
·Cardiovascular
Tempus LS - Manual
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Rapid Hair Removal Pads
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOLL E SERIES ALS
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOMED
FDA 510(k)
FDA Class 2
·Cardiovascular