The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Easy Diagnost.
| Device ID | K970640 |
| 510k Number | K970640 |
| Device Name: | PHILIPS EASY DIAGNOST |
| Classification | Table, Radiographic, Tilting |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074255 | K970640 | 000 |