COBE HEMODYNAMIC RECIRCULATION MONITOR— 510(k) K954003
Substantially EquivalentCobe Renal Care, Inc.
FDA 510(k) clearance K954003 for COBE HEMODYNAMIC RECIRCULATION MONITOR, Substantially Equivalent on 1997-02-06. Applicant: Cobe Renal Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Renal Care, Inc.
- Product code
- Code MQS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
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