FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

VENTILATOR PRESSURE ALARM MODEL VPA-100

K Number: K854934 · Decision Dec 24, 1985
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
27
Review Days
14

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Basic Information

Device Name
VENTILATOR PRESSURE ALARM MODEL VPA-100
K Number
K854934
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.2600
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Respiratory Support Products, Inc.
Date Received
December 10, 1985
Decision Date
December 24, 1985
Product Code
CAP
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
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (CAP), ordered by most recent decision date.

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Other Clearances by Respiratory Support Products, Inc.

K Number Device Name
K983862 CLOUD 1 HUMIDIFICATION SYSTEM
K921190 ADAP-TEMP TEMPERATURE SENSOR ADAPTER
K920469 MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
K921510 GAS SAMPLING KIT MODIFICATION
K913082 BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
K913083 BI-TEMP TEMPERATURE MONITOR TM-201D
K912280 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
K903816 URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
K874694 ADAP-TEMP, MODEL: AT-100
K873472 MEMBRANE HUMIDIFIER
Search all 27 clearances from Respiratory Support Products, Inc. →