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510(k) K871151

THE SPIRA ELEKTRO 2 by Warren E. Collins, Inc. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1987
Date Received
March 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

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  • K831780 — METABOLIC EXERCISE TESTING SYSTEM (September 12, 1983)
  • K831777 — COLLINS DS (August 31, 1983)
  • K831778 — RS-RESIDUAL VOLUME SYSTEM (August 31, 1983)
  • K831779 — COLLINS EAGLE II (August 26, 1983)
  • K803053 — APEXLINE OF PULMONARY FUNCT. INSTRUM. (December 22, 1980)
  • K803069 — SHELL KRATON THERMO-PLASTIC RUBBER COMP. (December 22, 1980)

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