The following data is part of a premarket notification filed by Philips Healthcare with the FDA for St80i Stress Test System.
| Device ID | K121638 |
| 510k Number | K121638 |
| Device Name: | ST80I STRESS TEST SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | PHILIPS HEALTHCARE 1525 RANCHO CONEJO BLVD SUITE 100 Thousand Oaks, CA 91320 |
| Contact | Gretal Lumley |
| Correspondent | Gretal Lumley PHILIPS HEALTHCARE 1525 RANCHO CONEJO BLVD SUITE 100 Thousand Oaks, CA 91320 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2012-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838030299 | K121638 | 000 |
| 00884838094840 | K121638 | 000 |