The following data is part of a premarket notification filed by Healthscan Products, Inc. with the FDA for Optichamber.
Device ID | K962822 |
510k Number | K962822 |
Device Name: | OPTICHAMBER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292 |
Contact | Lauren R Ziegler |
Correspondent | Lauren R Ziegler HEALTHSCAN PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-19 |
Decision Date | 1996-10-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPTICHAMBER 75055873 2084916 Live/Registered |
RESPIRONICS INC. 1996-02-09 |