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510(k) K141877

LEAF PATIENT MONITORING SYSTEM by Leaf Healthcare, Inc. — Product Code KMI

K141877 is an FDA 510(k) premarket notification submitted by Leaf Healthcare, Inc. for the device "LEAF PATIENT MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 2014. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2014
Date Received
July 11, 2014
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 for product code KMI

  • K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE (October 8, 2013)
  • 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)

FDA data resources