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

INTERTECH METERED DOSE ELBOW

K Number: K895144 · Decision Oct 19, 1989
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
10
Review Days
62

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Basic Information

Device Name
INTERTECH METERED DOSE ELBOW
K Number
K895144
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5810
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Intertech/Ohio
Date Received
August 18, 1989
Decision Date
October 19, 1989
Product Code
BZA
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
BZA Connector, Airway (Extension)

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Other Clearances by Intertech/Ohio

K Number Device Name
K890346 INTERTECH UNIVERSAL HYDROPHOBIC FILTER
K884525 PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
K884526 ADULT RESUSCITATOR WITH MASK AND FILTER
K882204 RESUSCITATOR VALVE ASSEMBLY W/FILTER
K880394 FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
K863033 PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
K862020 HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
K860650 90 DEGREE ELBOW & STRAIGHT CONNECTOR
K861056 STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG