The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Viewpoint - 3.0 Software.
| Device ID | K970604 |
| 510k Number | K970604 |
| Device Name: | VIEWPOINT - 3.0 SOFTWARE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Contact | Elaine K Keeler, Ph.d. |
| Correspondent | Elaine K Keeler, Ph.d. PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-05-19 |
| Summary: | summary |