The following data is part of a premarket notification filed by Eradlink, Inc. with the FDA for Laserpro 16.
| Device ID | K020243 |
| 510k Number | K020243 |
| Device Name: | LASERPRO 16 |
| Classification | Digitizer, Image, Radiological |
| Applicant | ERADLINK, INC. 19529 CHAPARRAL CIR. Penn Valley, CA 95946 -9443 |
| Contact | Albert J Kouba |
| Correspondent | Albert J Kouba ERADLINK, INC. 19529 CHAPARRAL CIR. Penn Valley, CA 95946 -9443 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-23 |
| Decision Date | 2002-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866389000167 | K020243 | 000 |