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510(k) K790668

VENOUS PRESSURE MONITOR, MF 35 LF by Deco Medical, Inc. — Product Code KRK

K790668 is an FDA 510(k) premarket notification submitted by Deco Medical, Inc. for the device "VENOUS PRESSURE MONITOR, MF 35 LF". The FDA issued a decision of Substantially Equivalent on May 23, 1979. The device falls under product code KRK (Manometer, Blood-Pressure, Venous), a Class II device regulated under 21 CFR 870.1140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
April 6, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Blood-Pressure, Venous
Device Class
Class II
Regulation Number
870.1140
Review Panel
CV
Submission Type

Other clearances for product code KRK

  • K950607 — UST-5268P-5 TRANSDUCER (September 15, 1995)
  • K904674 — CENTRAL VENOUS PRESSURE MANOMETER (December 27, 1990)
  • K884386 — ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (January 5, 1989)
  • K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (March 28, 1988)
  • K861605 — SCHNEIDER-SHILEY PRESSURE MANOMETER (May 28, 1986)
  • K830910 — MANOMETER SET C.V.P. #S 298/299 (April 5, 1983)
  • K813498 — MEDIFIX (January 7, 1982)
  • K813195 — MEDIFIX GRADUATED SCALE (December 29, 1981)

FDA data resources