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510(k) K946322

POLYGRAM SOFTWARE by Synectics Medical, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1995
Date Received
December 28, 1994
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

Other clearances by Synectics Medical, Inc.

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  • K961070 — ESOPHAGEAL MANOMETRY ANALYSIS MODULE (June 11, 1996)
  • K951442 — FLOLAB (August 24, 1995)
  • K942445 — SYNERGY II (November 22, 1994)

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