FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM
K Number: K837142
·
Decision Mar 23, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
79
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Basic Information
- Device Name
- TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM
- K Number
- K837142
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Hoffrel Instruments, Inc.
- Date Received
- January 3, 1983
- Decision Date
- March 23, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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 |
| K844916 | MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER | Apr 22, 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 |
| K800364 | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 | Mar 12, 1980 | Substantially Equivalent |
| K790396 | ULTRASONIC DIAGNOSTIC SYSTEM | Mar 21, 1979 | Substantially Equivalent |