Home / 510(k) Clearances / K925529

510(k) K925529

WANDER CARE by Care Electronics, Inc. — Product Code KMI

K925529 is an FDA 510(k) premarket notification submitted by Care Electronics, Inc. for the device "WANDER CARE". The FDA issued a decision of Substantially Equivalent on June 16, 1993. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. Care Electronics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1993
Date Received
November 2, 1992
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 Care Electronics, Inc.

  • K051681 — DERMILLUME RED, MODEL HR1000 (July 27, 2005)
  • K043575 — DERMILLUME, MODEL PRO1000 (February 24, 2005)

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)
  • 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)

FDA data resources