PERSONAL BEST LOW RANGE

Meter, Peak Flow, Spirometry

HEALTHSCAN PRODUCTS, INC.

The following data is part of a premarket notification filed by Healthscan Products, Inc. with the FDA for Personal Best Low Range.

Pre-market Notification Details

Device IDK933889
510k NumberK933889
Device Name:PERSONAL BEST LOW RANGE
ClassificationMeter, Peak Flow, Spirometry
Applicant HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove,  NJ  07009 -1292
ContactLauren R Ziegler
CorrespondentLauren R Ziegler
HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove,  NJ  07009 -1292
Product CodeBZH  
CFR Regulation Number868.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-10
Decision Date1993-09-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00383730000480 K933889 000
00383730000473 K933889 000
00383730000466 K933889 000
00383730000459 K933889 000

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