510(k) K813153
K813153 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "TEST MAGNET". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code DTG (Magnet, Test, Pacemaker), a Class I device regulated under 21 CFR 870.3690. Pacesetter Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1981
- Date Received
- November 6, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnet, Test, Pacemaker
- Device Class
- Class I
- Regulation Number
- 870.3690
- Review Panel
- CV
- Submission Type