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510(k) K862072

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 by International Biomedics, Inc. — Product Code HGL

K862072 is an FDA 510(k) premarket notification submitted by International Biomedics, Inc. for the device "FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01". The FDA issued a decision of Substantially Equivalent on July 9, 1986. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. International Biomedics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1986
Date Received
May 30, 1986
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 International Biomedics, Inc.

  • K031096 — MODIFICATION TO TRANSPORT INCUBATOR 185 (June 24, 2003)
  • K860933 — AIR-CUSHION TOCOTONOMETER (July 9, 1986)
  • K860295 — FETASCAN 1500 (May 19, 1986)
  • K852439 — FETA SCAN 1000 OBSTETRICAL IMAGER (August 30, 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)
  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)

FDA data resources