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510(k) K920783

OXYGEN FLOW CONTROLLER by Puritan Bennett Corp. — Product Code CCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1992
Date Received
February 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Device Class
Class I
Regulation Number
868.2300
Review Panel
AN
Submission Type

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  • K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION (October 20, 2000)
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  • K993220 — PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM (October 22, 1999)
  • K993088 — PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI (October 8, 1999)
  • K984535 — PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION (December 28, 1998)

Other clearances for product code CCN

  • K934945 — FLOWMETER NIPPLE ADAPTOR (November 17, 1993)
  • K872038 — NEB-U-VENT (August 10, 1987)
  • K871262 — MODIFIED NOFLO I (July 21, 1987)
  • K863613 — NO-FLO I (December 15, 1986)
  • K863657 — OXYGEN CONSERVATOR (October 15, 1986)
  • K863659 — FLOW INTERRUPTION INDICATOR (October 15, 1986)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)
  • K802037 — VITAMIN B12 FOLATE RADIOASSAY (November 21, 1980)