510(k) K941937
K941937 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "PIKOS E 01-B". The FDA issued a decision of SESP on August 30, 1994. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Biotronik, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESP ()
- Decision Date
- August 30, 1994
- Date Received
- April 21, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Pacemaker Pulse-Generator
- Device Class
- Class III
- Regulation Number
- 870.3610
- Review Panel
- CV
- Submission Type