510(k) K791795
K791795 is an FDA 510(k) premarket notification submitted by Medcraft Corp. for the device "COMP-ACT IV". The FDA issued a decision of Substantially Equivalent on September 27, 1979. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Medcraft Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1979
- Date Received
- September 14, 1979
- 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