The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Compurecord Peri-operative Anesthesiology Information System.
| Device ID | K083413 |
| 510k Number | K083413 |
| Device Name: | COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Teresa Schmidt |
| Correspondent | Teresa Schmidt PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-18 |
| Decision Date | 2008-12-18 |
| Summary: | summary |