The following data is part of a premarket notification filed by Nai Technology Products with the FDA for Nai Tech Products Medical Digital Recorder.
| Device ID | K042484 |
| 510k Number | K042484 |
| Device Name: | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER |
| Classification | Digitizer, Image, Radiological |
| Applicant | NAI TECHNOLOGY PRODUCTS 1342-D NORTH BENSON AVENUE Upland, CA 91786 |
| Contact | Robert E Johnson |
| Correspondent | Robert E Johnson NAI TECHNOLOGY PRODUCTS 1342-D NORTH BENSON AVENUE Upland, CA 91786 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2004-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850677007020 | K042484 | 000 |