FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF: RHEO DOPPLEX II
K Number: K984307
·
Decision Jan 12, 1999
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
14
Review Days
41
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Basic Information
- Device Name
- MODIFICATION OF: RHEO DOPPLEX II
- K Number
- K984307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huntleigh Healthcare, Inc.
- Date Received
- December 2, 1998
- Decision Date
- January 12, 1999
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA Class 2
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| 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 |
| K990569 | BABY DOPPLEX 4000, MODEL BD 4000 | Jan 24, 2000 | Substantially Equivalent |
| K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | Jan 26, 1998 | Substantially Equivalent |