510(k) K760510
K760510 is an FDA 510(k) premarket notification submitted by Medcraft Corp. for the device "MONITORING SYSTEM, REHABILITATION". The FDA issued a decision of Substantially Equivalent on August 30, 1976. 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
- August 30, 1976
- Date Received
- August 24, 1976
- 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