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510(k) K222460

Intraoperative Ultrasound Probe Cover by Exact Medical Manufacturing — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2023
Date Received
August 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K111535 — EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER (August 26, 2011)
  • K101598 — EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATION (October 4, 2010)
  • K101689 — EMM EQUIPMENT COVER-POLYTHYLENE (September 20, 2010)
  • 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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