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510(k) K837142

TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM by Hoffrel Instruments, Inc.

K837142 is an FDA 510(k) premarket notification submitted by Hoffrel Instruments, Inc. for the device "TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 1983. Hoffrel Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1983
Date Received
January 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K834277 — MOD 427 (February 17, 1984)
  • 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)
  • K800364 — ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (March 12, 1980)
  • K790396 — ULTRASONIC DIAGNOSTIC SYSTEM (March 21, 1979)

FDA data resources