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510(k) K211969

EMM Ultrasonic Transducer Cover by Exact Medical Manufacturing — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2021
Date Received
June 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 (September 20, 2010)
  • K101593 — EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-5 (September 3, 2010)

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