The following data is part of a premarket notification filed by Capsule Technologie with the FDA for Modification To Datacaptor.
| Device ID | K020197 |
| 510k Number | K020197 |
| Device Name: | MODIFICATION TO DATACAPTOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | CAPSULE TECHNOLOGIE PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm CAPSULE TECHNOLOGIE PO BOX 7007 Deerfield, IL 60015 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-22 |
| Decision Date | 2002-02-21 |
| Summary: | summary |