510(k) K802564
K802564 is an FDA 510(k) premarket notification submitted by Medical Concepts, Inc. for the device "MEDICAL MAGNETIC TAPE RECORDER". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Medical Concepts, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 17, 1980
- 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