The following data is part of a premarket notification filed by Capsule Technologie with the FDA for Datacaptor.
Device ID | K013019 |
510k Number | K013019 |
Device Name: | 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-07 |
Decision Date | 2001-12-18 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DATACAPTOR 90534647 not registered Live/Pending |
VSBLTY, Inc. 2021-02-18 |