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510(k) K030464

GEM, MODEL 004110 by Collins Medical, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2003
Date Received
February 12, 2003
Clearance Type
Special
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 Collins Medical, Inc.

  • K030917 — GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 (May 14, 2003)
  • K011344 — INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 (May 17, 2002)
  • K992743 — COLLINS CPL (September 13, 1999)

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