The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Td-7001nebulizer.
| Device ID | K122060 |
| 510k Number | K122060 |
| Device Name: | CLEVER TD-7001NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Contact | Pinjung Chen |
| Correspondent | Pinjung Chen TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-13 |
| Decision Date | 2013-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042012860 | K122060 | 000 |
| 00816042011474 | K122060 | 000 |
| 00816042011467 | K122060 | 000 |
| 00816042011146 | K122060 | 000 |