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510(k) K852909

MVP - 6000 by Waters Instruments, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

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  • K862161 — OSC-80 OXIMETER (August 18, 1986)
  • K834408 — TX-2 THERMAL DILUTION CARDIAC OUTPUT (August 23, 1984)
  • K841876 — POLYURETHANE THERMAL DILUTION CATHET (July 13, 1984)
  • K813585 — WATERS ILEOSTOMY VALVE (April 9, 1982)

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  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
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