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510(k) K813195

MEDIFIX GRADUATED SCALE by Burron Medical Products, Inc. — Product Code KRK

K813195 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "MEDIFIX GRADUATED SCALE". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code KRK (Manometer, Blood-Pressure, Venous), a Class II device regulated under 21 CFR 870.1140. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
November 12, 1981
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 by Burron Medical Products, Inc.

  • K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)
  • K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
  • K860126 — STIMUPLEX, NERVE STIMULATOR (February 28, 1986)
  • K851293 — IMPLANTOFIX (January 9, 1986)
  • K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
  • K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
  • K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
  • K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
  • K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)

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)
  • K790668 — VENOUS PRESSURE MONITOR, MF 35 LF (May 23, 1979)

FDA data resources