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510(k) K830470

ANESTHESIA BREATHING CIRCUITS by Mon-A-Therm, Inc. — Product Code CAI

K830470 is an FDA 510(k) premarket notification submitted by Mon-A-Therm, Inc. for the device "ANESTHESIA BREATHING CIRCUITS". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Mon-A-Therm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
Review Panel
AN
Submission Type

Other clearances by Mon-A-Therm, Inc.

  • K885187 — MODEL 1000 ELECTRONIC CLINICAL THERMOMETER (March 8, 1989)
  • K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSOR (January 29, 1988)
  • K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
  • K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSOR (January 19, 1988)
  • K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR (January 6, 1988)
  • K874524 — MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR (January 6, 1988)
  • K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (January 6, 1988)
  • K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSOR (January 6, 1988)
  • K874520 — MODIFIED AIRWAY TEMPERATURE SENSOR (January 6, 1988)
  • K853392 — MON-A-THERM SUBCUTANEOUS TEMP. SENSOR (November 22, 1985)

Other clearances for product code CAI

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources