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510(k) K900838

TRANSVAGINAL TRANSDUCER ASSEMBLY by Pie Medical Equipment B.V. — Product Code HGL

K900838 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "TRANSVAGINAL TRANSDUCER ASSEMBLY". The FDA issued a decision of Substantially Equivalent on May 23, 1990. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1990
Date Received
February 22, 1990
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 Pie Medical Equipment B.V.

  • K982203 — CAAS II LVA BIPLANE OPTION (July 14, 1998)
  • K945540 — CAAS II (June 28, 1995)
  • K915647 — DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 (November 9, 1992)
  • K912819 — SC1150 CW/PD (January 9, 1992)
  • K911584 — DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 (October 24, 1991)
  • K911043 — HEMISPHERE MULTIPLANE ENDORECTAL PROBE (October 9, 1991)
  • K911044 — 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) (October 7, 1991)

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)
  • 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