510(k) K761074
K761074 is an FDA 510(k) premarket notification submitted by Eldeco for the device "DYNAMIC RECORDER (DR-10)". The FDA issued a decision of Substantially Equivalent on Dec 28, 1976. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Eldeco has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 28, 1976
- Date Received
- Nov 19, 1976
- 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
- 510(k)