FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BABYBEAT CORDLESS
K Number: K061091
·
Decision May 4, 2006
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- BABYBEAT CORDLESS
- K Number
- K061091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Newman Group, LLC
- Date Received
- April 19, 2006
- Decision Date
- May 4, 2006
- Product Code
- KNG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by The Newman Group, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K090465 | DIGDOP ULTRASOUND SYSTEM | Apr 8, 2009 | Substantially Equivalent |