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510(k) K820248

RODDER VOLUME VENTILATOR by Pharmaquest Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
January 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Pharmaquest Corp.

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  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)
  • K833880 — TELEPHONIC RECEIVER R-10 EEG (November 29, 1983)
  • K830705 — MINI LANCET-BLOOD LANCET (April 8, 1983)
  • K822976 — HYPOCOUNT A (November 16, 1982)
  • K822486 — HOME BLOOD GLUCOSE MONITOR (November 5, 1982)
  • K812849 — PTT-200 TELEPHONIC PULMONARY TRANSMITT (December 3, 1981)
  • K812850 — PTT-200 PULMONARY RECEIVER/MICROPROCES (December 3, 1981)
  • K813010 — EEG TELEPHONE TRANSMITTER, MODEL #T-7 (November 16, 1981)
  • K812683 — NEONATE FLEXFLOAT (October 13, 1981)

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