BABYBEAT CORDLESS— 510(k) K061091
Substantially EquivalentThe Newman Group, LLC
FDA 510(k) clearance K061091 for BABYBEAT CORDLESS, Substantially Equivalent on 2006-05-04. Applicant: The Newman Group, LLC. Device class: 2.
Clearance details
- Applicant
- The Newman Group, LLC
- Product code
- Code KNG
- Device class
- Class 2
- Regulation
- 21 CFR 884.2660
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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