The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 4 Series Phototherapy Unit Model 4 Series.
| Device ID | K111172 |
| 510k Number | K111172 |
| Device Name: | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-26 |
| Decision Date | 2011-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B280807QS2000X6A1L0 | K111172 | 000 |
| B280807QS0020X60 | K111172 | 000 |
| B280807QS0020T60 | K111172 | 000 |
| B280807QS0010X60 | K111172 | 000 |
| B280807QS0010T60 | K111172 | 000 |
| B280807QS2000CX6A10 | K111172 | 000 |
| B280807QS2000CX60 | K111172 | 000 |
| B280807QS1000CX6A10 | K111172 | 000 |
| B280807QS1000CX60 | K111172 | 000 |
| B280806QS0020CX60 | K111172 | 000 |
| B280807QS1000T60 | K111172 | 000 |
| B280807QS1000T6A10 | K111172 | 000 |
| B280807QS2000X6A10 | K111172 | 000 |
| B280807QS2000X60 | K111172 | 000 |
| B280807QS2000T6A1L0 | K111172 | 000 |
| B280807QS2000T6A10 | K111172 | 000 |
| B280807QS2000T60 | K111172 | 000 |
| B280807QS1000X6A1L0 | K111172 | 000 |
| B280807QS1000X6A10 | K111172 | 000 |
| B280807QS1000X60 | K111172 | 000 |
| B280807QS1000T6A1L0 | K111172 | 000 |
| B280806QS0010CX60 | K111172 | 000 |