K910453 is an FDA 510(k) clearance for the TOPS NEEDLE TIP PROBE & PVC TIP PROBE. This device is classified as a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II - Special Controls, product code CCE).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on August 13, 1991, 193 days after receiving the submission on February 1, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1200.
| 510(k) Number | K910453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1991 |
| Decision Date | August 13, 1991 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1200 |