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510(k) K901142

MER MULTIPLANE VAGINAL PROBE (MVP) by Medical Equipment Resources — Product Code HGL

K901142 is an FDA 510(k) premarket notification submitted by Medical Equipment Resources for the device "MER MULTIPLANE VAGINAL PROBE (MVP)". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Medical Equipment Resources has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
March 12, 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 Medical Equipment Resources

  • K901033 — MER MULTIPLANE RECTAL PROBE (MRP) (August 22, 1990)

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)
  • 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