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

DEVILBISS PD1000

K Number: K020329 · Decision Jun 19, 2002
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
10
Review Days
139

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Basic Information

Device Name
DEVILBISS PD1000
K Number
K020329
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5905
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Sunrise Medical Hhg, Inc.
Date Received
January 31, 2002
Decision Date
June 19, 2002
Product Code
NFB
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
NFB Conserver, Oxygen

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Other Clearances by Sunrise Medical Hhg, Inc.

K Number Device Name
K083249 QUICKIE RHYTHM
K012437 DEVILBISS SLEEP RECORDER MODEL # RM60
K020900 DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
K011229 DEVILBISS 9000 SERIES CPAP, MODEL 9001
K003626 DEVILBISS HUMIDIFIER
K993492 DEVILBISS NEBULIZER MODEL 800
K991722 DEVILBISS 5 LITER OXYGEN CONCENTRATOR
K982304 DEVILBISS SUCTION UNIT
K981602 DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR