FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJINON EDU SYSTEM
K Number: K894763
·
Decision May 22, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
30
Review Days
299
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Basic Information
- Device Name
- FUJINON EDU SYSTEM
- K Number
- K894763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Fujinon, Inc.
- Date Received
- July 27, 1989
- Decision Date
- May 22, 1990
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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Other Clearances by Fujinon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | Aug 13, 2012 | Substantially Equivalent |
| K112391 | FUJINON COLONOSCOPES | Jul 26, 2012 | Substantially Equivalent |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | May 25, 2011 | Substantially Equivalent |
| K111243 | FUJINON ULTRASONIC PROCESSOR | May 16, 2011 | Substantially Equivalent |
| K091773 | FUJINON STERILE OVERTUBES | Aug 7, 2009 | Substantially Equivalent |
| K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | Apr 22, 2009 | Substantially Equivalent |
| K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION | Mar 16, 2007 | Substantially Equivalent |
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | Mar 1, 2007 | Substantially Equivalent |
| K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | May 19, 2005 | Substantially Equivalent |
| K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 | Nov 24, 2004 | Substantially Equivalent |