510(k) K912906
K912906 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "MEDGRAPHICS PF/DX". The FDA issued a decision of Substantially Equivalent on February 4, 1992. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1992
- Date Received
- July 2, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Oxygen-Uptake
- Device Class
- Class II
- Regulation Number
- 868.1730
- Review Panel
- AN
- Submission Type