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510(k) K030917

GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 by Collins Medical, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2003
Date Received
March 24, 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.

  • K030464 — GEM, MODEL 004110 (March 14, 2003)
  • K011344 — INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 (May 17, 2002)
  • K992743 — COLLINS CPL (September 13, 1999)

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  • K213754 — SpiroHome Personal, SpiroHome Clinic (June 12, 2023)
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  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)