Neocath 1000 Umbilical Artery Oxygen Monitoring Sy
FDA 510(k) K895149 · Shiley, Inc.
510(k) numberK895149
Submission
- Device name
- Neocath 1000 Umbilical Artery Oxygen Monitoring Sy
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- August 23, 1989
- Decision date
- November 28, 1989
- 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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| K895150 | Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K884063 | Bard Abg 100 Intravascular Oxygen Monitor SystemCCE · Traditional | C.R. Bard, Inc. | 12/16/1988SE |
| K875225 | Umbilical Artery Oxygen SensorCCE · Traditional | Ohmeda Medical | 03/04/1988SE |
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Questions and answers
When was Neocath 1000 Umbilical Artery Oxygen Monitoring Sy cleared by the FDA?
Neocath 1000 Umbilical Artery Oxygen Monitoring Sy (K895149) received a 510(k) decision of Substantially Equivalent on November 28, 1989, 97 days after the submission was received.
What is the product code of K895149?
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.