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510(k) K933798

NU-PREP GEL by Cadwell Laboratories, Inc. — Product Code GXB

K933798 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "NU-PREP GEL". The FDA issued a decision of Substantially Equivalent on April 22, 1994. The device falls under product code GXB (Esthesiometer), a Class I device regulated under 21 CFR 882.1500. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1994
Date Received
August 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esthesiometer
Device Class
Class I
Regulation Number
882.1500
Review Panel
NE
Submission Type

Other clearances by Cadwell Laboratories, Inc.

  • K061706 — CADWELL EASYNET OXIMETER MODULE (March 5, 2007)
  • K061705 — CADWELL EASYNET NASAL PRESSURE MODULE (November 21, 2006)
  • 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)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)

Other clearances for product code GXB

  • K143068 — Medical Monofilament Sensory Screening Toool (January 14, 2015)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K801907 — ALGESIOMETER (September 16, 1980)
  • K772406 — AESTHESIOMETER (January 6, 1978)
  • K771847 — TEMP-TESTER (November 2, 1977)
  • K761133 — AESTHESIOMETER (December 2, 1976)

FDA data resources