Home / 510(k) Clearances / K923335

510(k) K923335

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION by Advanced Medical Systems, Inc. — Product Code HGL

K923335 is an FDA 510(k) premarket notification submitted by Advanced Medical Systems, Inc. for the device "ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION". The FDA issued a decision of Substantially Equivalent on July 22, 1994. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Advanced Medical Systems, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1994
Date Received
June 8, 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 Advanced Medical Systems, Inc.

  • K955931 — MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) (August 14, 1996)
  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K940898 — MODEL IM77 INTRAPARTUM FETAL MONITOR (March 1, 1995)
  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K894568 — NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM (January 9, 1990)
  • K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER (June 16, 1989)
  • K880756 — MODEL PM-20A PHYSIOLOGICAL MONITOR (September 27, 1988)

Other clearances for product code HGL

  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • 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)
  • K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (December 18, 1989)

FDA data resources