Tops Needle Tip Probe & PVC Tip Probe
FDA 510(k) K910453 · Baxter Healthcare Corp
510(k) numberK910453
Submission
- Device name
- Tops Needle Tip Probe & PVC Tip Probe
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- February 1, 1991
- Decision date
- August 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
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Questions and answers
When was Tops Needle Tip Probe & PVC Tip Probe cleared by the FDA?
Tops Needle Tip Probe & PVC Tip Probe (K910453) received a 510(k) decision of Substantially Equivalent on August 13, 1991, 193 days after the submission was received.
What is the product code of K910453?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.