The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Philips Intellivue Tcg10.
| Device ID | K110474 |
| 510k Number | K110474 |
| Device Name: | PHILIPS INTELLIVUE TCG10 |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Jens-peter Seher |
| Correspondent | Jens-peter Seher PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | LKD |
| Subsequent Product Code | KLK |
| Subsequent Product Code | LPP |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-18 |
| Decision Date | 2011-09-30 |
| Summary: | summary |