The following data is part of a premarket notification filed by Hei, Inc. with the FDA for Heiter 3000 Hyperthermic Perfusion System.
| Device ID | K102900 |
| 510k Number | K102900 |
| Device Name: | HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | HEI, INC. 4801 NORTH 63RD. ST. Boulder, CO 80301 |
| Contact | Gregory Mathison |
| Correspondent | Gregory Mathison HEI, INC. 4801 NORTH 63RD. ST. Boulder, CO 80301 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2012-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719992086016 | K102900 | 000 |
| 08719992086009 | K102900 | 000 |