KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER— 510(k) K974389
Substantially EquivalentClinical Innovations, Inc.
FDA 510(k) clearance K974389 for KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER, Substantially Equivalent on 1998-02-19. Applicant: Clinical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, Inc.
- Product code
- Code HFN
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.