The following data is part of a premarket notification filed by Enraf-nonius B.v. with the FDA for Eltrac 471.
| Device ID | K151640 |
| 510k Number | K151640 |
| Device Name: | ELTRAC 471 |
| Classification | Equipment, Traction, Powered |
| Applicant | ENRAF-NONIUS B.V. VARSEWEG 127 Rotterdam, NL 3047 At |
| Contact | Anne-marie Van Maurik |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10660584000451 | K151640 | 000 |