SPIRO PD

Spirometer, Diagnostic

PMD HEALTHCARE

The following data is part of a premarket notification filed by Pmd Healthcare with the FDA for Spiro Pd.

Pre-market Notification Details

Device IDK103575
510k NumberK103575
Device Name:SPIRO PD
ClassificationSpirometer, Diagnostic
Applicant PMD HEALTHCARE 1468 HARWELL AVE. Crofton,  MD  21114
ContactE.j. Smith
CorrespondentE.j. Smith
PMD HEALTHCARE 1468 HARWELL AVE. Crofton,  MD  21114
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-06
Decision Date2011-11-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857845006007 K103575 000

Trademark Results [SPIRO PD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIRO PD
SPIRO PD
85453002 4325235 Live/Registered
PMD Healthcare
2011-10-21

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