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510(k) K981069

ULTRA-COVER PU-TRANSDUCER COVER by International Medical Products B.V. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1998
Date Received
March 24, 1998
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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  • K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE D (June 16, 1997)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
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  • K900755 — DIGITAL CUFF PV GAUGE (April 26, 1990)
  • K864984 — ROBINJECT (June 29, 1987)
  • K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (February 25, 1987)
  • K861539 — NIKKISO INFUSION PUMP MODEL PFA-02 (July 31, 1986)

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