The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Intellispace Ecg.
| Device ID | K120855 |
| 510k Number | K120855 |
| Device Name: | INTELLISPACE ECG |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-21 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838090750 | K120855 | 000 |
| 00884838032408 | K120855 | 000 |
| 00884838093478 | K120855 | 000 |