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510(k) K991045

MINI-LOGGER SERIES 2000 by Mini-Mitter Co., Inc. — Product Code GWK

K991045 is an FDA 510(k) premarket notification submitted by Mini-Mitter Co., Inc. for the device "MINI-LOGGER SERIES 2000". The FDA issued a decision of Substantially Equivalent on September 21, 1999. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Mini-Mitter Co., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1999
Date Received
March 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

Other clearances by Mini-Mitter Co., Inc.

  • K033534 — VITALSENSE (April 22, 2004)
  • K011430 — ACTIWARE-PLMS (May 31, 2001)
  • K991033 — ACTIWATCH-SCORE (June 23, 1999)
  • K983533 — ACTIWATCH (March 23, 1999)

Other clearances for product code GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)
  • K860914 — ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (June 6, 1986)

FDA data resources