Home / 510(k) Clearances / K131585

510(k) K131585

INTEL-GE CARE INNOVATIONS QUIETCARE by Intel-Ge Care Innovations, LLC — Product Code KMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2013
Date Received
May 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Bed Patient
Device Class
Class I
Regulation Number
880.2400
Review Panel
HO
Submission Type

Other clearances by Intel-Ge Care Innovations, LLC

  • K130821 — INTEL-GE CARE INNOVATIONS CONNECT RCM (August 9, 2013)
  • K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE (June 4, 2013)

Other clearances for product code KMI

  • K141877 — LEAF PATIENT MONITORING SYSTEM (November 10, 2014)
  • K130752 — DYNASENSE SYSTEM (August 15, 2013)
  • K101109 — VIVATRAK (July 15, 2010)
  • K090138 — MOBILECARE MONITOR, MODEL 2100 (April 24, 2009)
  • K942770 — ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (December 23, 1994)
  • K943481 — INFORMER PLUS (November 2, 1994)
  • K933552 — PM-PAGER (September 22, 1994)
  • K934344 — HOME AMB-ALERT (April 29, 1994)
  • K940405 — TELETOM (April 14, 1994)
  • K924433 — SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 (June 24, 1993)