FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAESTRO DIGITAL VIDEO SYSTEM
K Number: K920373
·
Decision Jun 24, 1992
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
19
Review Days
147
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Basic Information
- Device Name
- MAESTRO DIGITAL VIDEO SYSTEM
- K Number
- K920373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- International Imaging Electronics
- Date Received
- January 29, 1992
- Decision Date
- June 24, 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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Other Clearances by International Imaging Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K972019 | PEFECT SHOT | Jul 3, 1997 | Substantially Equivalent |
| K970964 | MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM | Jun 13, 1997 | Substantially Equivalent |
| K953165 | ULTRA COMPACT VIDEO IMAGER | May 7, 1996 | Substantially Equivalent |
| K950330 | DIGITAL IMAGE ACQUISITION SYSTEM | May 7, 1996 | Substantially Equivalent |
| K940332 | MODEL FORTY ULTRA COMPACT VIDEO IMAGER | Jun 8, 1994 | Substantially Equivalent |
| K934908 | FULL VIEW DIGITAL STORAGE SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K930755 | ULTRA COMPACT VIDEO IMAGER | Sep 28, 1993 | Substantially Equivalent |
| K930765 | ULTRA COMPACT VIDEO IMAGER | Sep 13, 1993 | Substantially Equivalent |
| K921992 | MP3000 SERIES III VIDEO IMAGER | Jul 10, 1992 | Substantially Equivalent |
| K904897 | MODEL 400 ULTRA COMPACT VIDEO IMAGER | Nov 20, 1990 | Substantially Equivalent |