510(k) K935518
K935518 is an FDA 510(k) premarket notification submitted by Epm Information Systems, Inc. for the device "MOVING IMAGES(TM)". The FDA issued a decision of Substantially Equivalent - Subject to Tracking Reg. on May 17, 1994. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Epm Information Systems, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- ST (Substantially Equivalent - Subject to Tracking Reg.)
- Decision Date
- May 17, 1994
- Date Received
- Nov 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type
- 510(k)