510(k) K960849
K960849 is an FDA 510(k) premarket notification submitted by Cardiac Assist Devices, Inc. for the device "MAGNO ALARM". The FDA issued a decision of Substantially Equivalent on March 26, 1997. The device falls under product code DTG (Magnet, Test, Pacemaker), a Class I device regulated under 21 CFR 870.3690. Cardiac Assist Devices, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1997
- Date Received
- February 20, 1996
- 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