510(k) K910453
K910453 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "TOPS NEEDLE TIP PROBE & PVC TIP PROBE". The FDA issued a decision of Substantially Equivalent on August 13, 1991. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1991
- Date Received
- February 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1200
- Review Panel
- AN
- Submission Type