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510(k) K891540

EDENTEC MODEL 2860 PRESSURE METER by Edentec Corp. — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1989
Date Received
March 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

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  • K893561 — EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (August 25, 1989)
  • K892227 — EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) (June 20, 1989)

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