The following data is part of a premarket notification filed by Quality Life Technologies Co;ltd with the FDA for Quality Life Technologies Compressor Nebulizer.
| Device ID | K112824 |
| 510k Number | K112824 |
| Device Name: | QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | QUALITY LIFE TECHNOLOGIES CO;LTD 3500 S.DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu QUALITY LIFE TECHNOLOGIES CO;LTD 3500 S.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 | 2011-09-28 |
| Decision Date | 2012-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841447104012 | K112824 | 000 |