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510(k) K090138

MOBILECARE MONITOR, MODEL 2100 by Aframe Digital, Inc. — Product Code KMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2009
Date Received
January 21, 2009
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 Aframe Digital, Inc.

  • K122333 — MOBILECARE MONITOR (November 19, 2012)

Other clearances for product code KMI

  • K141877 — LEAF PATIENT MONITORING SYSTEM (November 10, 2014)
  • K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE (October 8, 2013)
  • K130752 — DYNASENSE SYSTEM (August 15, 2013)
  • K101109 — VIVATRAK (July 15, 2010)
  • 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)