510(k) K791566
K791566 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MODEL AS* 6C INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Nov 13, 1979. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 13, 1979
- Date Received
- Aug 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Scale, Patient
- Device Class
- Class I
- Regulation Number
- 880.2720
- Review Panel
- HO
- Submission Type
- 510(k) Exempt