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510(k) K834277

MOD 427 by Hoffrel Instruments, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
October 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Hoffrel Instruments, Inc.

  • K870850 — MOD 482 (September 8, 1987)
  • K860235 — MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER (May 15, 1986)
  • K850165 — MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 (October 23, 1985)
  • K844916 — MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER (April 22, 1985)
  • K834276 — MOD 456 (February 17, 1984)
  • K837282 — MODEL VPS VASCULAR PROFILE SYSTEM (April 26, 1983)
  • K837229 — TRANSDUCER MODELS 450, 451, 452, 453, 454 (April 15, 1983)
  • K837142 — TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM (March 23, 1983)
  • K800364 — ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (March 12, 1980)
  • K790396 — ULTRASONIC DIAGNOSTIC SYSTEM (March 21, 1979)

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