510(k) K896345
K896345 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "EXERCISE EVALUATION SYSTEM 2010". The FDA issued a decision of Substantially Equivalent on January 20, 1990. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1990
- Date Received
- November 3, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Interpretor (Diagnostic)
- Device Class
- Class II
- Regulation Number
- 868.1900
- Review Panel
- AN
- Submission Type