FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER
K Number: K844916
·
Decision Apr 22, 1985
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
12
Review Days
125
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Basic Information
- Device Name
- MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER
- K Number
- K844916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Hoffrel Instruments, Inc.
- Date Received
- December 18, 1984
- Decision Date
- April 22, 1985
- 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 Hoffrel Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870850 | MOD 482 | Sep 8, 1987 | Substantially Equivalent |
| K860235 | MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER | May 15, 1986 | Substantially Equivalent |
| K850165 | MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 | Oct 23, 1985 | Substantially Equivalent |
| K834276 | MOD 456 | Feb 17, 1984 | Substantially Equivalent |
| K834277 | MOD 427 | Feb 17, 1984 | Substantially Equivalent |
| K837282 | MODEL VPS VASCULAR PROFILE SYSTEM | Apr 26, 1983 | Substantially Equivalent |
| K837229 | TRANSDUCER MODELS 450, 451, 452, 453, 454 | Apr 15, 1983 | Substantially Equivalent |
| K837142 | TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM | Mar 23, 1983 | Substantially Equivalent |
| K800364 | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 | Mar 12, 1980 | Substantially Equivalent |
| K790396 | ULTRASONIC DIAGNOSTIC SYSTEM | Mar 21, 1979 | Substantially Equivalent |