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510(k) K854976

RMI RESPIRATORY GATING SYSTEM MODEL 301 by Radiation Measurements, Inc. — Product Code IXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1986
Date Received
December 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Synchronizer, Ecg / Respirator, Radiographic
Device Class
Class I
Regulation Number
892.1970
Review Panel
RA
Submission Type

Other clearances by Radiation Measurements, Inc.

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  • K873956 — ULTIMETER (October 30, 1987)
  • K873836 — MAMMOGRAPHIC KVP METER MODEL 232 (October 16, 1987)
  • K834483 — DIGI-X (March 5, 1984)
  • K834607 — ELECTRONIC KVP CASSETTE (February 21, 1984)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 1984)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K837033 — ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 (March 9, 1983)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

Other clearances for product code IXO

  • K811587 — SIEMENS ANGIOTRON (July 10, 1981)
  • K810588 — SYNCHRONIZER #208 (April 10, 1981)
  • K791959 — POST EXTRA SYSTOLIC POSTENTLATOR (January 9, 1980)