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510(k) K013205

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 by Millar Instruments, Inc. — Product Code DRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
September 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type

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  • K896264 — MILLAR MIKRO-TIP DOPPLER CATHETER (January 24, 1990)
  • K895721 — MILLAR MIKRO-TIP PULSE TRANSDUCER (December 7, 1989)
  • K883651 — MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER (November 18, 1988)
  • K860766 — MILLAR PULSED DOPPLER VELOCIMETER (July 29, 1986)

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