510(k) K810529
K810529 is an FDA 510(k) premarket notification submitted by Elmed, Inc. for the device "DIRECT WRITING VECTORCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code DYC (Vectorcardiograph), a Class II device regulated under 21 CFR 870.2400. Elmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- February 26, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vectorcardiograph
- Device Class
- Class II
- Regulation Number
- 870.2400
- Review Panel
- CV
- Submission Type