510(k) K830605
K830605 is an FDA 510(k) premarket notification submitted by Biomedical Devices, Inc. for the device "PUMP PALL AMBULATORY INSULIN INFUSION". The FDA issued a decision of Substantially Equivalent on March 31, 1983. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Biomedical Devices, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1983
- Date Received
- February 25, 1983
- 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