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510(k) K770896

COLPOSCOPE MODEL II by Dynatech Cryomedical Co. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1977
Date Received
May 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

Other clearances by Dynatech Cryomedical Co.

  • K771898 — AUTOMATED SLIDE SPINNER (October 18, 1977)
  • K771815 — SIGMOSCOPE (October 7, 1977)
  • K770614 — MONITOR, GAS MANIFOLD (April 7, 1977)
  • K761205 — DYNATECH JD7/JD7P COLPOSCOPE (December 17, 1976)
  • K760763 — COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I (October 20, 1976)

Other clearances for product code HEX

  • K233043 — Smart Scope® CX (June 14, 2024)
  • K190187 — Gynescope System (May 8, 2019)
  • K182764 — Biop Digital Colposcope (November 27, 2018)
  • K181034 — Pocket Colposcope System (September 21, 2018)
  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K161871 — EVA (Enhanced Visual Assessment) System (December 19, 2016)
  • K160341 — Colposcope System (September 14, 2016)
  • K160380 — LT-300 HD (May 13, 2016)
  • K151878 — Video Colposcope (December 1, 2015)
  • K143119 — LT-300 Video Colposcope (December 18, 2014)