510(k) K940842
K940842 is an FDA 510(k) premarket notification submitted by Unipower Corp. for the device "UNIPOWER RECHARGEABLE BATTERY PACK". The FDA issued a decision of ST on September 7, 1994. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Unipower Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- September 7, 1994
- Date Received
- February 23, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device Class
- Class II
- Regulation Number
- 870.5300
- Review Panel
- CV
- Submission Type