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510(k) K790328

MODEL 1051, MONITOR by Applied Medical Research — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1979
Date Received
February 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Applied Medical Research

  • K800025 — DINAMAP RESEARCH MONITOR 1245 (February 1, 1980)
  • K791580 — CEREBRAL FUNCTION MONITOR 870 (September 4, 1979)
  • K791159 — DINAMAP MODEL 855 (July 30, 1979)
  • K790322 — OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 (May 14, 1979)
  • K782073 — DINAMAP MODELS 1160 AND 1165 (February 23, 1979)
  • K781064 — DINAMAP MODEL 848 (September 7, 1978)
  • K781053 — DINAMAP MODEL 846 (September 7, 1978)
  • K781311 — ELECTRODE, NEEDLE, CFM (August 21, 1978)
  • K780754 — NEONATAL MONITOR (June 14, 1978)
  • K780759 — MODEL 902 STAND (May 19, 1978)

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