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510(k) K770984

TA-2 TEMPERATURE ALARM by Mistogen Equipment Co. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1977
Date Received
May 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

Other clearances by Mistogen Equipment Co.

  • K801619 — MIST2GEN TEMPTROL 10 (August 4, 1980)
  • K781591 — NEBULIZER/HUMIDIFIER MODEL EH 147B (October 16, 1978)
  • K760341 — HUMIDIFIER, ELECTRONIC (EH147) (August 11, 1976)

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