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510(k) K950607

UST-5268P-5 TRANSDUCER by Aloka Co., Ltd. — Product Code KRK

K950607 is an FDA 510(k) premarket notification submitted by Aloka Co., Ltd. for the device "UST-5268P-5 TRANSDUCER". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code KRK (Manometer, Blood-Pressure, Venous), a Class II device regulated under 21 CFR 870.1140. Aloka Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
February 9, 1995
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 Aloka Co., Ltd.

  • K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM (May 13, 2011)
  • K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (February 17, 2011)
  • K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM (November 20, 2009)
  • K083254 — ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM (December 19, 2008)
  • K081843 — ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 (July 15, 2008)
  • K080176 — ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM (February 29, 2008)
  • K072285 — ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (August 30, 2007)
  • K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM (January 13, 2006)
  • K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM (November 30, 2004)
  • K040719 — ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM (March 26, 2004)

Other clearances for product code KRK

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

FDA data resources