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 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 |
NIH GUDID Devices
| 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 |
Trademark Results [OPTICHAMBER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTICHAMBER 75055873 2084916 Live/Registered |
RESPIRONICS INC. 1996-02-09 |
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