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510(k) K884386

ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK by Ethitek Pharmaceuticals Co. — Product Code KRK

K884386 is an FDA 510(k) premarket notification submitted by Ethitek Pharmaceuticals Co. for the device "ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK". The FDA issued a decision of Substantially Equivalent on January 5, 1989. 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
January 5, 1989
Date Received
October 18, 1988
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)
  • 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)
  • K790668 — VENOUS PRESSURE MONITOR, MF 35 LF (May 23, 1979)

FDA data resources