The following data is part of a premarket notification filed by Eradlink, Inc. with the FDA for Cr-pro.
| Device ID | K052938 |
| 510k Number | K052938 |
| Device Name: | CR-PRO |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ERADLINK, INC. 22750 HAWTHORNE BLVD. Torrance, CA 90505 -3664 |
| Contact | Albert Kouba |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866389000198 | K052938 | 000 |
| 00866389000181 | K052938 | 000 |
| 00866389000150 | K052938 | 000 |