FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MULTIPURPOSE TRANSDUCER RANGE
K Number: K874192
·
Decision Jul 19, 1988
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
5
Review Days
279
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Basic Information
- Device Name
- MULTIPURPOSE TRANSDUCER RANGE
- K Number
- K874192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Pie Data Medical BV
- Date Received
- October 14, 1987
- Decision Date
- July 19, 1988
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Pie Data Medical BV
| K Number | Device Name | ||
|---|---|---|---|
| K870653 | ULTRASOUND LINEAR/SECTOR SCANNER 1100 | Feb 2, 1988 | Substantially Equivalent |
| K870058 | PIE MEDICAL SCANNER 1000 | Feb 2, 1988 | Substantially Equivalent |
| K874081 | ENTERSCAN | Dec 31, 1987 | Substantially Equivalent |
| K871082 | FETAL CARE MONITOR ANTEPARTUM 1500 | Aug 4, 1987 | Substantially Equivalent |