510(k) K822961
K822961 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PORTA FIB III". The FDA issued a decision of Substantially Equivalent on Nov 1, 1982. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Narco Scientific has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 1, 1982
- Date Received
- Oct 5, 1982
- 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
- 510(k)