510(k) K910471
K910471 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE". The FDA issued a decision of Substantially Equivalent on March 8, 1991. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1991
- Date Received
- February 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type