The following data is part of a premarket notification filed by Philips Medical Systems (cleveland), Inc. with the FDA for Ebw Nm 2.0.
| Device ID | K111336 |
| 510k Number | K111336 |
| Device Name: | EBW NM 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 3860 N. FIRST STREET San Jose, CA 95134 |
| Contact | Lori R Peterson |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2011-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838115637 | K111336 | 000 |
| 00884838121577 | K111336 | 000 |