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510(k) K893232

MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM by Camino Laboratories, Inc. — Product Code DSK

K893232 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
April 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

Other clearances by Camino Laboratories, Inc.

  • K932769 — CAMINO VENTRICULAR DRAINAGE SYSTEM (March 30, 1995)
  • K930222 — CAMINO VENTRICULAR ACCESS DEVICE (April 15, 1993)
  • K930221 — CAMINO VENTRICULAR TRANSDUCER ACCESSORY (April 15, 1993)
  • K920088 — CAMINO VENTRICULAR NEEDLE (May 1, 1992)
  • K914735 — VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM (January 17, 1992)
  • K912833 — CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (September 23, 1991)
  • K881183 — VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H (May 4, 1988)
  • K863969 — CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D (May 27, 1987)
  • K861961 — CAMINO CSF DRAINAGE SYSTEM MODEL 040 (August 12, 1986)
  • K862160 — CAMINO HAND DRILL - MODEL 030 (July 18, 1986)

Other clearances for product code DSK

  • K231586 — Endophys Blood Pressure Monitor model BPM-30 (November 3, 2023)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)
  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K013943 — RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (December 18, 2001)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)

FDA data resources