510(k) K896396
K896396 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "MIDA SYSTEM, MODELS 1000/1100". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code DYC (Vectorcardiograph), a Class II device regulated under 21 CFR 870.2400. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1990
- Date Received
- November 6, 1989
- 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