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510(k) K905586

RSVP RF-2000 by Tactilitics, Inc. — Product Code KMI

K905586 is an FDA 510(k) premarket notification submitted by Tactilitics, Inc. for the device "RSVP RF-2000". The FDA issued a decision of Substantially Equivalent on April 1, 1991. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. Tactilitics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1991
Date Received
December 6, 1990
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 Tactilitics, Inc.

  • K864827 — RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR (January 21, 1987)

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