The following data is part of a premarket notification filed by Cardiac Insight, Inc. with the FDA for Stealth System, Stealth Sensor, Stealth Smart Cable, Stealthview Software.
| Device ID | K162503 |
| 510k Number | K162503 |
| Device Name: | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Cardiac Insight, Inc. 3230 Carillon Point Kirkland, WA 98033 |
| Contact | Brad Harlow |
| Correspondent | Dan Tylutki Cardiac Insight, Inc. 3230 Carillon Point Kirkland, WA 98033 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-07 |
| Decision Date | 2017-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094212471 | K162503 | 000 |
| 00732094212464 | K162503 | 000 |
| 00857553006092 | K162503 | 000 |
| 20857553006072 | K162503 | 000 |
| 00857553006122 | K162503 | 000 |
| 10857553006112 | K162503 | 000 |
| 00732094296358 | K162503 | 000 |
| 00732094296334 | K162503 | 000 |