510(k) K911400
K911400 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "WALKAWAY TM 40". The FDA issued a decision of Substantially Equivalent on Nov 19, 1991. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 19, 1991
- Date Received
- Mar 29, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)