LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL

Humidifier, Respiratory Gas, (direct Patient Interface)

MAUNA LOA MEDICAL, INC.

The following data is part of a premarket notification filed by Mauna Loa Medical, Inc. with the FDA for Lavabed System & Chamber, Lavapak Temp. Control.

Pre-market Notification Details

Device IDK870173
510k NumberK870173
Device Name:LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant MAUNA LOA MEDICAL, INC. 3387 CHICAGO AVE. Riverside,  CA  92507
ContactJames Weigl
CorrespondentJames Weigl
MAUNA LOA MEDICAL, INC. 3387 CHICAGO AVE. Riverside,  CA  92507
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-14
Decision Date1987-04-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00709078012136 K870173 000
00709078001864 K870173 000
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00709078006005 K870173 000
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10709078002288 K870173 000
10709078002271 K870173 000
00709078002229 K870173 000
00709078002205 K870173 000
00850018561648 K870173 000

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