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510(k) K770678

ELC-THERMO-SYSTEM by Cutter Laboratories, Inc. — Product Code KXZ

K770678 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "ELC-THERMO-SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 1977. The device falls under product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)), a Class III device regulated under 21 CFR 884.2982. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1977
Date Received
April 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Device Class
Class III
Regulation Number
884.2982
Review Panel
RA
Submission Type

Other clearances by Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)

Other clearances for product code KXZ

  • K851034 — NOVATHERM (September 27, 1985)
  • K843124 — Q-SCAN THERMOGRAPHY SYSTEM (November 29, 1984)
  • K832731 — BREAST & BODY HEALTH SYSTEM 2000 (January 30, 1984)
  • K813547 — THERMASCAN (March 12, 1982)
  • K781916 — FLEXT-THERM (February 2, 1979)
  • K770986 — FLEXI-THERM FILM (September 12, 1977)

FDA data resources