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510(k) K904625

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM by Synectics-Dantec — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1991
Date Received
October 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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  • K914793 — MONOCRYSTANT PH/LES CATHETER, MODIFICATION (December 13, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K913817 — MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (June 11, 1992)
  • K914624 — PH METER, MODIFICATION (April 28, 1992)
  • K914219 — AIRWAY THERMISTOR (February 26, 1992)
  • K913387 — DIGITRAPPER MARK III (December 27, 1991)
  • K905520 — MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION (April 26, 1991)

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