510(k) K883037
K883037 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "UNILITH 3 MODELS 7580/7583/7680/7683". The FDA issued a decision of Substantially Equivalent on January 25, 1989. 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
- January 25, 1989
- Date Received
- July 19, 1988
- 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