510(k) K904462
K904462 is an FDA 510(k) premarket notification submitted by Cardiotronics, Inc. for the device "MODEL #210 STEALTH DEFIB PADS". The FDA issued a decision of Substantially Equivalent on December 3, 1990. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Cardiotronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1990
- Date Received
- October 1, 1990
- 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