The following data is part of a premarket notification filed by Spaulding Clinical Research, Llc with the FDA for Spaulding Electrocardiograph 2100iq.
| Device ID | K150564 |
| 510k Number | K150564 |
| Device Name: | Spaulding Electrocardiograph 2100iQ |
| Classification | Electrocardiograph |
| Applicant | Spaulding Clinical Research, LLC 525 S.Silverbrook Drive West Bend, WI 53095 |
| Contact | Andre Leak |
| Correspondent | Andre Leak Spaulding Clinical Research, LLC 525 S.Silverbrook Drive West Bend, WI 53095 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-06 |
| Decision Date | 2015-08-12 |
| Summary: | summary |