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510(k) K840380

UTERINE SOUND by Intl. Medical Technologies, Inc. — Product Code HHM

K840380 is an FDA 510(k) premarket notification submitted by Intl. Medical Technologies, Inc. for the device "UTERINE SOUND". The FDA issued a decision of Substantially Equivalent on April 30, 1984. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. Intl. Medical Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1984
Date Received
January 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sound, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Intl. Medical Technologies, Inc.

  • K840381 — TAPERED CERVICAL DILATOR (April 30, 1984)
  • K840384 — DIAGNOSTIC DILATATION & MENSTRUAL KIT (April 30, 1984)
  • K840383 — MENSTRUAL ASPIRATION KIT (April 30, 1984)
  • K840382 — VACUUM ASPIRATION CATHETER (April 30, 1984)

Other clearances for product code HHM

  • K011840 — CERVILENZ UTERINE MEASURING SOUND (August 10, 2001)
  • K935665 — INTRAUTERINE SOUND (February 24, 1994)
  • K884684 — ROCKET INTRAUTERINE DEPTH SOUND (December 20, 1988)
  • K883806 — ROCKET INTRAUTERINE SOUND (October 31, 1988)
  • K870550 — TEFLON UTERINE SOUND (March 4, 1987)
  • K831224 — AUGROS HYSTEROMETER (October 28, 1983)
  • K802315 — UTERINE SOUND (January 12, 1981)
  • K781766 — UTERINE SOUND, BURNETT DISPOSABLE (December 7, 1978)
  • K760170 — INTRAUTERINE SOUND, PLASTIC DISPOSABLE (July 19, 1976)

FDA data resources