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510(k) K771714

SLIDE STAINERS GLS 360 & 360-1 by Honeywell, Inc. — Product Code KEY

K771714 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "SLIDE STAINERS GLS 360 & 360-1". The FDA issued a decision of Substantially Equivalent on October 5, 1977. The device falls under product code KEY (Stainer, Tissue, Automated), a Class I device regulated under 21 CFR 864.3800. Honeywell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1977
Date Received
September 12, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stainer, Tissue, Automated
Device Class
Class I
Regulation Number
864.3800
Review Panel
PA
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)

FDA data resources