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510(k) K812682

FLEXFLOAT HEATER by Pharmaquest Corp. — Product Code FOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1981
Date Received
September 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Water, Temperature Regulated
Device Class
Class I
Regulation Number
880.5560
Review Panel
HO
Submission Type

Other clearances by Pharmaquest Corp.

  • K945519 — FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE AN (November 3, 1995)
  • K833880 — TELEPHONIC RECEIVER R-10 EEG (November 29, 1983)
  • K833236 — TELEPHONE TRANSMITTER T-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)
  • K820248 — RODDER VOLUME VENTILATOR (April 16, 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)

Other clearances for product code FOH

  • K954216 — OLYMPIC WARM-BASSINET (December 8, 1995)
  • K872876 — IMSI/EASY FLOAT MATTRESS (October 13, 1987)
  • K812683 — NEONATE FLEXFLOAT (October 13, 1981)
  • K812681 — ADULT FLEX FLOAT W/HEATER (October 8, 1981)
  • K812684 — ADULT FLEXFLOAT (October 8, 1981)