510(k) K874571
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1988
- Date Received
- November 5, 1987
- Clearance Type
- Traditional
- 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