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510(k) K760999

THERMOGRAPH, MEDICAL by Honeywell, Inc. — Product Code IYM

K760999 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "THERMOGRAPH, MEDICAL". The FDA issued a decision of Substantially Equivalent on November 19, 1976. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980. Honeywell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1976
Date Received
November 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic, Infrared
Device Class
Class III
Regulation Number
884.2980
Review Panel
RA
Submission Type

Other clearances by Honeywell, Inc.

  • K902230 — COLORADO COLOR IMAGING RECORDER (June 19, 1990)
  • K863100 — CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR (February 3, 1987)
  • K853501 — HONEYWELL ELECTRONIC VENTILATOR EV-A (April 4, 1986)
  • K855125 — PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM (March 26, 1986)
  • K851888 — APM DISPOS. BLOOD PRESSURE TRANSDUCER (August 6, 1985)
  • K851496 — ECG MONITOR MODEL RM102 (July 24, 1985)
  • K850794 — PATIENT MONITOR MODEL RM-300 (April 18, 1985)
  • K851092 — PORTABLE DEFIBRILLATOR/MONITOR ED 425 (April 10, 1985)
  • K834530 — EXTENSION BOX EB200 (June 1, 1984)
  • K834282 — ULTRA IMAGER 2000 (April 23, 1984)

Other clearances for product code IYM

  • K863736 — FMS MODEL 110 (December 29, 1986)
  • K852950 — VISITHERM (February 7, 1986)
  • K823041 — JEOL MODEL #JTG-500M (November 24, 1982)
  • K812799 — DCATS (October 20, 1981)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)
  • K801553 — THERMOCOMP (October 31, 1980)
  • K800491 — GRAPHIC STRESS TELETHERMOMETRY (March 4, 1980)

FDA data resources