510(k) K960449
K960449 is an FDA 510(k) premarket notification submitted by Biosensor Corp. for the device "PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)". The FDA issued a decision of Substantially Equivalent on May 30, 1996. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Biosensor Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1996
- Date Received
- January 30, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type