The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Disposable Medication Nebulizer.
Device ID | K791536 |
510k Number | K791536 |
Device Name: | DISPOSABLE MEDICATION NEBULIZER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | HOSPITAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-10 |
Decision Date | 1979-09-07 |