510(k) K781678
K781678 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "DEFIBRILLATOR, MARK II". The FDA issued a decision of Substantially Equivalent on December 12, 1978. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1978
- Date Received
- October 2, 1978
- 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