510(k) K770366
K770366 is an FDA 510(k) premarket notification submitted by Electronics For Medicine, Inc. for the device "ISOLATED ELECTROCARDIOGRAPH MODEL 1207". The FDA issued a decision of Substantially Equivalent on Mar 1, 1977. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Electronics For Medicine, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 1977
- Date Received
- Feb 23, 1977
- 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
- 510(k)