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510(k) K992743

COLLINS CPL by Collins Medical, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1999
Date Received
August 16, 1999
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)
  • K030464 — GEM, MODEL 004110 (March 14, 2003)
  • K011344 — INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 (May 17, 2002)

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  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)