510(k) K801704
K801704 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "OPEN-LOOP INSULIN DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Delta Medical Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1980
- Date Received
- July 24, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type