The following data is part of a premarket notification filed by Cardiac Insight, Inc. with the FDA for Stealth Monitor, Stealth Docking Cable, Stealth Dsd Software Installation Disk, Stealth System.
| Device ID | K142468 |
| 510k Number | K142468 |
| Device Name: | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARDIAC INSIGHT, INC. 2815 EASTLAKE AVE. E., STE#300 Seattle, WA 98102 |
| Contact | Brad Harlow |
| Correspondent | Deborah Sheffield DEBORAH L. SHEFFIELD CONSULTING 5672 FLAGLER ROAD Norland, WA 98358 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2015-07-11 |
| Summary: | summary |