The following data is part of a premarket notification filed by Capsule Surveillance Technologies, Sas /capsule Tech, Inc. with the FDA for Capsule Surveillance System.
| Device ID | K213335 |
| 510k Number | K213335 |
| Device Name: | Capsule Surveillance System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Capsule Surveillance Technologies, SAS /Capsule Tech, Inc. 300 Brickstone Square Suite 203 Andover, MA 01810 |
| Contact | Peter Kelley |
| Correspondent | Peter Kelley Capsule Surveillance Technologies, SAS /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 | 2021-10-06 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03615041990332 | K213335 | 000 |
| 03615041990394 | K213335 | 000 |
| 03615041990431 | K213335 | 000 |
| 03615041990455 | K213335 | 000 |
| 03615041990479 | K213335 | 000 |
| 03615041990486 | K213335 | 000 |
| 03615041990509 | K213335 | 000 |
| 03615041990516 | K213335 | 000 |
| 03615041990547 | K213335 | 000 |
| 03615041990554 | K213335 | 000 |
| 03615041990363 | K213335 | 000 |