The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Drug Nebulizer.
Device ID | K760580 |
510k Number | K760580 |
Device Name: | DRUG NEBULIZER |
Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCQ |
CFR Regulation Number | 868.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-03 |
Decision Date | 1976-09-21 |