FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
UNIPOWER RECHARGEABLE BATTERY PACK
K Number: K940842
·
Decision Sep 7, 1994
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
3
Review Days
196
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Basic Information
- Device Name
- UNIPOWER RECHARGEABLE BATTERY PACK
- K Number
- K940842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Unipower Corp.
- Date Received
- February 23, 1994
- Decision Date
- September 7, 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 |
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