510(k) K897096
K897096 is an FDA 510(k) premarket notification submitted by Dynatech/Nevada, Inc. for the device "MODEL 404A I.V. INFUSION PUMP ANALYZER". The FDA issued a decision of Substantially Equivalent on March 15, 1990. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Dynatech/Nevada, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1990
- Date Received
- December 21, 1989
- 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