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510(k) K781542

HEATED NEBULIZER by Chemetron Medical Products, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
September 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Chemetron Medical Products, Inc.

  • K781706 — RESPIRATOR/GILL 1/SIMV (January 22, 1979)
  • K781537 — NEBULIZER/HUMIDIFIER (October 10, 1978)
  • K781541 — FLOMETER (September 26, 1978)

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