The following data is part of a premarket notification filed by Eidosmed, Llc with the FDA for Eidosmed, Model Edg4.0.
| Device ID | K091992 |
| 510k Number | K091992 |
| Device Name: | EIDOSMED, MODEL EDG4.0 |
| Classification | Electronic Depth Gauge |
| Applicant | EIDOSMED, LLC 333 MILFORD RD Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm EIDOSMED, LLC 333 MILFORD RD Deerfield, IL 60015 |
| Product Code | OOL |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2009-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865707000414 | K091992 | 000 |