The following data is part of a premarket notification filed by Precision One Lifecare, Ltd. with the FDA for Precision One Lifecare; Detecto; Detecto.
| Device ID | K130952 |
| 510k Number | K130952 |
| Device Name: | PRECISION ONE LIFECARE; DETECTO; DETECTO |
| Classification | Analyzer, Body Composition |
| Applicant | PRECISION ONE LIFECARE, LTD. PO BOX 3515 Redmond, WA 98073 |
| Contact | Steven Chernoff |
| Correspondent | Steven Chernoff PRECISION ONE LIFECARE, LTD. PO BOX 3515 Redmond, WA 98073 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2013-09-26 |
| Summary: | summary |