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510(k) K834607

ELECTRONIC KVP CASSETTE by Radiation Measurements, Inc. — Product Code IWN

K834607 is an FDA 510(k) premarket notification submitted by Radiation Measurements, Inc. for the device "ELECTRONIC KVP CASSETTE". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code IWN (Cassette, Measurement, Ardran-Crooks), a Class I device regulated under 21 CFR 892.1940. Radiation Measurements, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
December 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Measurement, Ardran-Crooks
Device Class
Class I
Regulation Number
892.1940
Review Panel
RA
Submission Type

Other clearances by Radiation Measurements, Inc.

  • K893216 — RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (September 5, 1989)
  • K885223 — RMI SHORT DISTANCE ALIGNMENT DEVICE (February 17, 1989)
  • K873956 — ULTIMETER (October 30, 1987)
  • K873836 — MAMMOGRAPHIC KVP METER MODEL 232 (October 16, 1987)
  • K854976 — RMI RESPIRATORY GATING SYSTEM MODEL 301 (May 7, 1986)
  • K834483 — DIGI-X (March 5, 1984)
  • K834481 — DOPPLER PHANTOM FLOW CONTROL SYS (January 25, 1984)
  • K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMS (January 25, 1984)
  • K837033 — ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 (March 9, 1983)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

FDA data resources