Home / 510(k) Clearances / K912833

510(k) K912833

CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY by Camino Laboratories, Inc. — Product Code DSK

K912833 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY". The FDA issued a decision of Substantially Equivalent on September 23, 1991. 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
September 23, 1991
Date Received
June 26, 1991
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)
  • K893232 — MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM (July 14, 1989)
  • 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