The following data is part of a premarket notification filed by Vectracor, Inc. with the FDA for Universal Smartecg.
| Device ID | K173952 |
| 510k Number | K173952 |
| Device Name: | Universal SmartECG |
| Classification | Electrocardiograph |
| Applicant | VectraCor, Inc. 785 Totowa Rd. Suite 100 Totowa, NJ 07512 |
| Contact | Andrew Schreck |
| Correspondent | Andrew Schreck VectraCor, Inc. 785 Totowa Rd. Suite 100 Totowa, NJ 07512 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-27 |
| Decision Date | 2018-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857175006173 | K173952 | 000 |