The following data is part of a premarket notification filed by Ironmaster, Inc. with the FDA for Esp7 Venous Image.
| Device ID | K982612 |
| 510k Number | K982612 |
| Device Name: | ESP7 VENOUS IMAGE |
| Classification | Device, Vein Location, Liquid Crystal |
| Applicant | IRONMASTER, INC. 1719 GRANT ST. Santa Clara, CA 95050 |
| Contact | Fred Dawson |
| Correspondent | Fred Dawson IRONMASTER, INC. 1719 GRANT ST. Santa Clara, CA 95050 |
| Product Code | KZA |
| CFR Regulation Number | 880.6970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1998-12-14 |
| Summary: | summary |