The following data is part of a premarket notification filed by Capsule Tech Inc. with the FDA for Datacaptor System.
| Device ID | K113835 |
| 510k Number | K113835 |
| Device Name: | DATACAPTOR SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | CAPSULE TECH INC. 300 Brickstone Square Suite 203 Andover, MA 01810 |
| Contact | Peter Kelley |
| Correspondent | Peter Kelley CAPSULE TECH INC. 300 Brickstone Square Suite 203 Andover, MA 01810 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-06-27 |
| Summary: | summary |