FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA PCI
K Number: K921426
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
14
Review Days
195
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Basic Information
- Device Name
- ULTRA PCI
- K Number
- K921426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Medical Products, Inc.
- Date Received
- March 24, 1992
- Decision Date
- October 5, 1992
- 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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| K896102 | MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR | Jan 18, 1990 | Substantially Equivalent |
| K881905 | MODEL MICRO SI AMBULATORY ECG MONITOR | Aug 2, 1988 | Substantially Equivalent |
| K872508 | MODEL MICRO FD+ AMBULATORY ECG MONITOR | Sep 25, 1987 | Substantially Equivalent |
| K870537 | MODEL MICRO ST AMBULATORY ECG MONITOR | Apr 23, 1987 | Substantially Equivalent |
| K870538 | MODEL 192 PRINTER | Apr 23, 1987 | Substantially Equivalent |