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510(k) K833227

SONICAID MODEL D206E AIR EMBOLI-DETECT by Sonicaid, Inc. — Product Code LBA

K833227 is an FDA 510(k) premarket notification submitted by Sonicaid, Inc. for the device "SONICAID MODEL D206E AIR EMBOLI-DETECT". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code LBA (Procainamide Control Materials), a Class I device regulated under 21 CFR 862.3280. Sonicaid, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1983
Date Received
August 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Procainamide Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
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)
  • K833488 — SONICOMP (November 28, 1983)
  • K831371 — MODEL FM5 (June 30, 1983)

FDA data resources