PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM

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 Ii With Zone Management System.

Pre-market Notification Details

Device IDK962924
510k NumberK962924
Device Name:PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
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 Received1996-07-29
Decision Date1996-10-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00383730004563 K962924 000
00383730004648 K962924 000
00383730004617 K962924 000
50885403174825 K962924 000

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