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510(k) K061705

CADWELL EASYNET NASAL PRESSURE MODULE by Cadwell Laboratories, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2006
Date Received
June 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Cadwell Laboratories, Inc.

  • K061706 — CADWELL EASYNET OXIMETER MODULE (March 5, 2007)
  • K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (November 3, 2004)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)
  • K971214 — KILOWIN (June 11, 1998)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)
  • K933808 — EEG CUP ELECTRODE (December 29, 1994)

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