510(k) K042708
K042708 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "ERA 3000 PACING SYSTEM ANALYZER". The FDA issued a decision of Substantially Equivalent on October 20, 2004. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Biotronik, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2004
- Date Received
- September 30, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pulse-Generator, Pacemaker, External
- Device Class
- Class II
- Regulation Number
- 870.3600
- Review Panel
- CV
- Submission Type