510(k) K900461
K900461 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "OPUS MODEL 4021, VVI, 5MM UNIPOLAR". The FDA issued a decision of Substantially Equivalent on March 14, 1990. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1990
- Date Received
- January 31, 1990
- 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