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510(k) K837229

TRANSDUCER MODELS 450, 451, 452, 453, 454 by Hoffrel Instruments, Inc.

K837229 is an FDA 510(k) premarket notification submitted by Hoffrel Instruments, Inc. for the device "TRANSDUCER MODELS 450, 451, 452, 453, 454". The FDA issued a decision of Substantially Equivalent on April 15, 1983. Hoffrel Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1983
Date Received
March 1, 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)
  • K834276 — MOD 456 (February 17, 1984)
  • K834277 — MOD 427 (February 17, 1984)
  • K837282 — MODEL VPS VASCULAR PROFILE SYSTEM (April 26, 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)

FDA data resources