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510(k) K130752

DYNASENSE SYSTEM by Centauri Medical, Inc. — Product Code KMI

K130752 is an FDA 510(k) premarket notification submitted by Centauri Medical, Inc. for the device "DYNASENSE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 15, 2013. 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
August 15, 2013
Date Received
March 19, 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 for product code KMI

  • K141877 — LEAF PATIENT MONITORING SYSTEM (November 10, 2014)
  • K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE (October 8, 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