FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

ANESTHESIA BREATHING CIRCUITS

K Number: K830470 · Decision Mar 24, 1983
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
17
Review Days
37

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Basic Information

Device Name
ANESTHESIA BREATHING CIRCUITS
K Number
K830470
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5240
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Mon-A-Therm, Inc.
Date Received
February 15, 1983
Decision Date
March 24, 1983
Product Code
CAI
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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Other Clearances by Mon-A-Therm, Inc.

K Number Device Name
K885187 MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K874522 MODIFIED MYOCARDIAL TEMPERATURE SENSOR
K874519 MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
K875234 MON-A-THERM'S SKIN TEMPERATURE SENSOR
K874525 MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
K874524 MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
K874523 MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
K874521 MODIFIED THERMAL WELL TEMPERATURE SENSOR
K874520 MODIFIED AIRWAY TEMPERATURE SENSOR
K853392 MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
Search all 17 clearances from Mon-A-Therm, Inc. →