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510(k) K910982

INNERVISION IRRIGATION PUMP by M.D. Engineering, Inc. — Product Code HEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
March 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by M.D. Engineering, Inc.

  • K912882 — INNERVISION LAPAROSCOPE AND ACCESSORIES (January 24, 1992)
  • K910983 — IV 1000 INSUFFLATOR RAPID FLOW (December 9, 1991)
  • K883384 — TS1000 SUCTION TIP (November 2, 1988)

Other clearances for product code HEI

  • K012003 — DRG REACTION CHAMBER/SAFETY TIP (February 12, 2002)
  • K920985 — SNOWDEN-PENCER IRRIGATION PUMP (June 9, 1992)