510(k) K920530
K920530 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG". The FDA issued a decision of Substantially Equivalent on March 17, 1992. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Intermedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1992
- Date Received
- February 5, 1992
- 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