FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BABY DOPPLEX 4000, MODEL BD 4000
K Number: K990569
·
Decision Jan 24, 2000
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
14
Review Days
335
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Basic Information
- Device Name
- BABY DOPPLEX 4000, MODEL BD 4000
- K Number
- K990569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huntleigh Healthcare, Inc.
- Date Received
- February 23, 1999
- Decision Date
- January 24, 2000
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Huntleigh Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032315 | IOP8 INTRA OPERATIVE PROBE | Nov 18, 2004 | Substantially Equivalent |
| K022786 | DVT60 | Sep 19, 2002 | Substantially Equivalent |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | Mar 26, 2002 | Substantially Equivalent |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | Sep 21, 2001 | Substantially Equivalent |
| K002186 | VASCULAR ASSIST | May 2, 2001 | Substantially Equivalent |
| K010894 | BABY DOPPLEX 3002 (BD3002) | Apr 25, 2001 | Substantially Equivalent |
| K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) | Apr 25, 2001 | Substantially Equivalent |
| K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 | Sep 19, 2000 | Substantially Equivalent |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | Jan 12, 1999 | Substantially Equivalent |
| K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | Jan 26, 1998 | Substantially Equivalent |