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510(k) K771685

AMPLIFIER MODEL N5A-HIS by Honeywell, Inc. — Product Code DRJ

K771685 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "AMPLIFIER MODEL N5A-HIS". The FDA issued a decision of Substantially Equivalent on September 14, 1977. The device falls under product code DRJ (System, Signal Isolation), a Class I device regulated under 21 CFR 870.2600. Honeywell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1977
Date Received
September 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Signal Isolation
Device Class
Class I
Regulation Number
870.2600
Review Panel
CV
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 DRJ

  • K832828 — CENTURION CARDIAC DETECTOR (May 9, 1984)
  • K822590 — PRESSURE ISOLATION AMPLIFIER #9813 517 (October 4, 1982)
  • K771684 — AMPLIFIER MODEL N5A-ECG (September 14, 1977)

FDA data resources