The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Compurecord Peri-operative Information System Software.
Device ID | K030939 |
510k Number | K030939 |
Device Name: | PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE |
Classification | Gas-machine, Anesthesia |
Applicant | PHILIPS MEDICAL SYSTEMS 1082 BOWER HILL RD. Pittsburgh, PA 15243 |
Contact | Judith K Phillips |
Correspondent | Judith K Phillips PHILIPS MEDICAL SYSTEMS 1082 BOWER HILL RD. Pittsburgh, PA 15243 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-25 |
Decision Date | 2003-07-15 |
Summary: | summary |