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510(k) K921878

SCANMATE III by Circadian, Inc. — Product Code IYP

K921878 is an FDA 510(k) premarket notification submitted by Circadian, Inc. for the device "SCANMATE III". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code IYP (Phantom, Anthropomorphic, Nuclear), a Class I device regulated under 21 CFR 892.1370. Circadian, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
April 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phantom, Anthropomorphic, Nuclear
Device Class
Class I
Regulation Number
892.1370
Review Panel
RA
Submission Type

Other clearances by Circadian, Inc.

  • K894956 — CIRCAMED HOLTER VERSION 4 (February 5, 1990)
  • K874641 — CIRCADIAN STRESS TEST II (April 1, 1988)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K871251 — CIRCAMED FULL DISCLOSURE SYSTEM (May 22, 1987)
  • K860973 — CIRCADIAN STRESS TEST SYSTEM (August 25, 1986)
  • K851517 — CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO (October 2, 1985)
  • K851643 — REMOTE CONTROL MODULE (September 9, 1985)
  • K840741 — PULMONARY FUNCTION TESTING STS (March 5, 1984)
  • K833619 — CONDUCTANCE METER (January 27, 1984)
  • K830830 — CIRCA MED TWO-CHANNEL (June 18, 1983)

Other clearances for product code IYP

  • K844189 — LINEAR SCANNER PROBE ELSCINT LTD. TL-35 (February 25, 1985)
  • K812893 — SUPERFLAB (December 8, 1981)

FDA data resources