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510(k) K924586

CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE by Capintec Instruments, Inc. — Product Code IZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1992
Date Received
September 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Uptake, Nuclear
Device Class
Class I
Regulation Number
892.1320
Review Panel
RA
Submission Type

Other clearances by Capintec Instruments, Inc.

  • K943072 — BETA C COUNTER (September 29, 1994)
  • K935539 — CAPINTEC CRC 35R (February 18, 1994)
  • K930962 — CAPTUS 2000 WEL COUNTER (May 18, 1993)
  • K921428 — CAPTUS 500 (May 28, 1992)
  • K910020 — CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (April 8, 1991)
  • K905796 — DOSE CALIBRATOR (March 18, 1991)

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  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)