NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY— 510(k) K895149
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K895149 for NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY, Substantially Equivalent on 1989-11-28. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- Product code
- Code CCE
- Device class
- Class 2
- Regulation
- 21 CFR 868.1200
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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