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510(k) K833488

SONICOMP by Sonicaid, Inc. — Product Code HEM

K833488 is an FDA 510(k) premarket notification submitted by Sonicaid, Inc. for the device "SONICOMP". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Sonicaid, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
October 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by Sonicaid, Inc.

  • K873673 — BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (February 26, 1988)
  • K872074 — 5 MHZ TRANSDUCER (August 25, 1987)
  • K863803 — VASOPULSE(TM)/MODEL 5000 (May 6, 1987)
  • K862720 — VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (November 17, 1986)
  • K861237 — VASOVIEW DUPLEX IMAGING SYSTEM (July 14, 1986)
  • K851102 — VASOSCREEN IMPEDANCE PLETHYSMOGRAPH (May 16, 1985)
  • K833902 — VASOSCAN (January 27, 1984)
  • K832374 — PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (December 1, 1983)
  • K833227 — SONICAID MODEL D206E AIR EMBOLI-DETECT (October 27, 1983)
  • K831371 — MODEL FM5 (June 30, 1983)

Other clearances for product code HEM

  • K951393 — ABACUS OB ULTRASOUNG COMPUTER SOFTWARE (May 1, 1995)
  • K942490 — BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND (February 15, 1995)
  • K910426 — SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT (June 6, 1991)
  • K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (January 31, 1991)
  • K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER (August 10, 1990)
  • K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (April 19, 1990)
  • K890637 — EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE (June 12, 1989)
  • K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (April 14, 1989)
  • K885061 — SIEMENS INTRAVAGINAL TRANSDUCER (February 23, 1989)
  • K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)

FDA data resources