The following data is part of a premarket notification filed by Etectrx, Inc. with the FDA for Id-cap System.
| Device ID | K183052 |
| 510k Number | K183052 |
| Device Name: | ID-Cap System |
| Classification | Ingestible Event Marker |
| Applicant | etectRx, Inc. 747 SW 2nd Ave Suite 365T, IMB 24 Gainesville, FL 32601 |
| Contact | Susan Baumgartner |
| Correspondent | Paul Dryden etectRx, Inc. 747 SW 2nd Ave Suite 365T, IMB 24 Gainesville, FL 32601 |
| Product Code | OZW |
| CFR Regulation Number | 880.6305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-12-06 |