510(k) K780813
K780813 is an FDA 510(k) premarket notification submitted by Iso-Data, Inc. for the device "IDI GDR DATA REDUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 1978. Iso-Data, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1978
- Date Received
- May 15, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No