510(k) K901736
K901736 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "OXIMETRY PROBE CATHETERS". The FDA issued a decision of Substantially Equivalent on Sep 11, 1990. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 1990
- Date Received
- Apr 17, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Oximeter, Fiber-Optic
- Device Class
- Class II
- Regulation Number
- 870.1230
- Review Panel
- CV
- Submission Type
- 510(k)