SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000— 510(k) K003458
Substantially EquivalentClinical Innovations, Inc.
FDA 510(k) clearance K003458 for SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000, Substantially Equivalent on 2001-05-03. Applicant: Clinical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, Inc.
- Product code
- Code HGP
- Device class
- Class 2
- Regulation
- 21 CFR 884.2675
- 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.