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510(k) K924516

OP3/VP4 by Huntleigh Technology, Inc. — Product Code HGL

K924516 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "OP3/VP4". The FDA issued a decision of Substantially Equivalent on June 28, 1993. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1993
Date Received
September 4, 1992
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 Huntleigh Technology, Inc.

  • K992733 — AKRON ATP9 TRACTION MACHINE (November 10, 1999)
  • K964699 — RHEO DOPPLEX II (RD 2) (February 21, 1997)
  • K910188 — FLOWPLUS AC330 PUMP GARMENTS (May 28, 1991)
  • K900882 — MULTI DOPPLEX, MD-1 (August 22, 1990)
  • K900618 — HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 (April 25, 1990)
  • K890012 — HUNTLEIGH DYNAMIC FLOTATION SYSTEM (March 29, 1989)
  • K884451 — DOPCORD PPG (January 12, 1989)
  • K881632 — FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT (September 26, 1988)
  • K874688 — FLOWTRON AC200/2 (September 23, 1988)
  • K882644 — HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 (August 10, 1988)

Other clearances for product code HGL

  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • 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)
  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)
  • K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (December 18, 1989)

FDA data resources