OPTICHAMBER

Nebulizer (direct Patient Interface)

HEALTHSCAN PRODUCTS, INC.

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

Pre-market Notification Details

Device IDK962822
510k NumberK962822
Device Name:OPTICHAMBER
ClassificationNebulizer (direct Patient Interface)
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 CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-19
Decision Date1996-10-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00383730001203 K962822 000
00383730001197 K962822 000
00383730001180 K962822 000
00383730001173 K962822 000
00383730001166 K962822 000
00383730001159 K962822 000
00383730001142 K962822 000
00383730001135 K962822 000
00383730001128 K962822 000

Trademark Results [OPTICHAMBER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTICHAMBER
OPTICHAMBER
75055873 2084916 Live/Registered
RESPIRONICS INC.
1996-02-09

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