510(k) K894494
K894494 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Biotronik, GmbH & Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1989
- Date Received
- July 19, 1989
- 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