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

MODEL LP-3 PORTABLE VOLUME VENTILATOR

K Number: K770132 · Decision Feb 1, 1977
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
10
Review Days
11

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Basic Information

Device Name
MODEL LP-3 PORTABLE VOLUME VENTILATOR
K Number
K770132
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5895
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Life Products, Inc.
Date Received
January 21, 1977
Decision Date
February 1, 1977
Product Code
CBK
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
CBK Ventilator, Continuous, Facility Use

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K901714 LIFESTYLE HOME TANNING UNITS
K854022 LPA-1 PRESSURE MONITOR
K850151 L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
K851905 LPA-2 REMOTE ALARM
K851805 LPA-3 PRINTER
K842122 4A
K844179 LP-5
K844081 LP4 VENTILATOR
K844290 L100D PATIENT CIRCUIT DUAL LINE