The following data is part of a premarket notification filed by Spaulding Clinical Research, Llc with the FDA for Spaulding Iq Electrocardiograph.
| Device ID | K110065 |
| 510k Number | K110065 |
| Device Name: | SPAULDING IQ ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | SPAULDING CLINICAL RESEARCH, LLC 525 S. SILVERBROOK DRIVE West Bend, WI 53095 |
| Contact | Paul Schultz |
| Correspondent | Paul Schultz 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-03-02 |
| Summary: | summary |