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510(k) K897151

ACUSON V328 AND C5432 TRANSDUCERS by Acuson Corp. — Product Code JTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1990
Date Received
December 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport Systems, Anaerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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Other clearances for product code JTX

  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K882637 — ACCU-CULSHURE TM (July 6, 1988)
  • K791724 — BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (October 17, 1979)
  • K781376 — STANDARDIZE TGCL & TGCH (September 14, 1978)
  • K780159 — ANASWAB (February 13, 1978)
  • K761241 — PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (December 30, 1976)
  • K760063 — SPECIMEN COLLECTOR, ANAEROBIC (August 3, 1976)