The following data is part of a premarket notification filed by Dongguan Aidisy Machinery & Electronic Equipment C with the FDA for Compressor Nebulizer Model Mcn-s600xx.
| Device ID | K123030 |
| 510k Number | K123030 |
| Device Name: | COMPRESSOR NEBULIZER MODEL MCN-S600XX |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488570919 | K123030 | 000 |
| 05060488570902 | K123030 | 000 |
| 05060488570896 | K123030 | 000 |
| 05060488570841 | K123030 | 000 |
| 05060488573637 | K123030 | 000 |
| 05060488573613 | K123030 | 000 |
| 05060488573590 | K123030 | 000 |