510(k) K062007
K062007 is an FDA 510(k) premarket notification submitted by Diagnostic Monitoring Software for the device "DMS 300-7". The FDA issued a decision of Substantially Equivalent on August 16, 2006. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Diagnostic Monitoring Software has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2006
- Date Received
- July 17, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type