510(k) K023471
K023471 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on October 29, 2002. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2002
- Date Received
- October 15, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Insulin
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type