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510(k) K842462

HOLTER SCREENING MONITOR HS-221 by Advantage Medical Systems, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
June 22, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Advantage Medical Systems, Inc.

  • K873957 — NON-CORING HUBER TYPE NEEDLES (October 23, 1987)
  • K873290 — LACERATION AND INSTRUMENT TRAYS (September 24, 1987)
  • K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (December 22, 1986)
  • K861556 — MODIFIED FETAL MONITOR MODEL FM-2 (July 7, 1986)
  • K861279 — FLUORO PLUS (June 16, 1986)
  • K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER (May 30, 1986)
  • K852518 — MODIFICATION FETAL MONITOR MODEL FM-2 (July 5, 1985)
  • K844724 — FETAL TELEMETRY SYSTEM (May 1, 1985)
  • K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100P (June 19, 1984)
  • K832849 — FETAL MONITOR #FM-2 (October 4, 1983)

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