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510(k) K780754

NEONATAL MONITOR by Applied Medical Research — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1978
Date Received
May 9, 1978
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)
  • K790328 — MODEL 1051, MONITOR (March 2, 1979)
  • K782073 — DINAMAP MODELS 1160 AND 1165 (February 23, 1979)
  • K781053 — DINAMAP MODEL 846 (September 7, 1978)
  • K781064 — DINAMAP MODEL 848 (September 7, 1978)
  • K781311 — ELECTRODE, NEEDLE, CFM (August 21, 1978)
  • K780759 — MODEL 902 STAND (May 19, 1978)

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