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510(k) K881263

MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER by Multigon Industries, Inc. — Product Code HGL

K881263 is an FDA 510(k) premarket notification submitted by Multigon Industries, Inc. for the device "MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER". The FDA issued a decision of Substantially Equivalent on January 5, 1990. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Multigon Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1990
Date Received
March 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

Other clearances by Multigon Industries, Inc.

  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)
  • K051739 — POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPL (July 28, 2005)
  • K912044 — MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR (June 24, 1991)
  • K882755 — MODEL 500V VASCULAR SPECTRUM ANALYZER (November 29, 1988)
  • K863589 — MODEL 600 VASCULAR DUPLEX IMAGER (June 24, 1987)
  • K860435 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER (May 5, 1986)
  • K852680 — TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG (December 23, 1985)

Other clearances for product code HGL

  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K924516 — OP3/VP4 (June 28, 1993)
  • K903348 — ULTRASONIC PULSED DOPPLER IMAGING SYSTEM (October 22, 1990)
  • K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (September 12, 1990)
  • K903316 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (August 22, 1990)
  • K901142 — MER MULTIPLANE VAGINAL PROBE (MVP) (August 22, 1990)
  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)
  • K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM (March 5, 1990)
  • K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (December 18, 1989)

FDA data resources