The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Calg-str Exercise Ecg Analysis Algorithm.
| Device ID | K112959 |
| 510k Number | K112959 |
| Device Name: | CALG-STR EXERCISE ECG ANALYSIS ALGORITHM |
| Classification | Electrocardiograph |
| Applicant | PHILIPS HEALTHCARE 1525 RANCHO CONEJO BLVD SUITE 100 Thousand Oaks, CA 91320 |
| Contact | Gretel Lumley |
| Correspondent | Gretel Lumley PHILIPS HEALTHCARE 1525 RANCHO CONEJO BLVD SUITE 100 Thousand Oaks, CA 91320 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2012-01-26 |
| Summary: | summary |