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510(k) K923335

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

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

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Other clearances for product code HGL

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  • K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (September 12, 1990)
  • K901142 — MER MULTIPLANE VAGINAL PROBE (MVP) (August 22, 1990)
  • K903316 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (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)